Trial Outcomes & Findings for Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes (NCT NCT01289990)

NCT ID: NCT01289990

Last Updated: 2014-07-15

Results Overview

Change from baseline in HbA1c after 52 weeks

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2705 participants

Primary outcome timeframe

Baseline and 52 weeks

Results posted on

2014-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Empagliflozin 10 mg (Drug Naive) Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Drug Naive) Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Drug Naive) Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Sitagliptin 100mg (Drug Naive) Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100mg: Sitagliptin once daily	Empagliflozin 10 mg (Pioglitazone) Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Pioglitazone) Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Pioglitazone) Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin) Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	Empagliflozin 25 mg (Metformin) Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin) Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
Overall Study STARTED	224	224	228	223	165	168	166	217	214	207	226	218	225
Overall Study COMPLETED	147	143	119	136	93	94	78	162	139	121	150	150	127
Overall Study NOT COMPLETED	77	81	109	87	72	74	88	55	75	86	76	68	98

Reasons for withdrawal

Reasons for withdrawal
Measure	Empagliflozin 10 mg (Drug Naive) Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Drug Naive) Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Drug Naive) Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Sitagliptin 100mg (Drug Naive) Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100mg: Sitagliptin once daily	Empagliflozin 10 mg (Pioglitazone) Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Pioglitazone) Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Pioglitazone) Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin) Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	Empagliflozin 25 mg (Metformin) Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin) Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
Overall Study Death	0	0	0	1	2	1	0	0	0	0	0	1	0
Overall Study Lost to Follow-up	3	2	5	5	3	4	2	2	1	4	2	1	2
Overall Study Withdrawal by Subject	15	14	12	13	8	7	13	9	12	13	11	13	16
Overall Study discontinued in preceding trial	18	20	41	17	11	12	18	8	17	21	17	17	24
Overall Study did not continue in extension	41	45	51	51	48	50	54	36	44	48	45	34	56
Overall Study Not treated	0	0	0	0	0	0	1	0	1	0	1	2	0

Baseline Characteristics

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empagliflozin 10 mg (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Sitagliptin 100 mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100 mg: Sitagliptin once daily	Empagliflozin 10 mg (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin) n=217 Participants Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	Empagliflozin 25 mg (Metformin) n=213 Participants Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Total n=2700 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 11.6 • n=5 Participants	53.8 years STANDARD_DEVIATION 11.6 • n=7 Participants	54.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	55.1 years STANDARD_DEVIATION 9.9 • n=4 Participants	54.7 years STANDARD_DEVIATION 9.9 • n=21 Participants	54.2 years STANDARD_DEVIATION 8.9 • n=10 Participants	54.6 years STANDARD_DEVIATION 10.5 • n=115 Participants	55.5 years STANDARD_DEVIATION 9.9 • n=6 Participants	55.6 years STANDARD_DEVIATION 10.2 • n=6 Participants	56.0 years STANDARD_DEVIATION 9.7 • n=64 Participants	57.0 years STANDARD_DEVIATION 9.2 • n=17 Participants	57.4 years STANDARD_DEVIATION 9.3 • n=21 Participants	56.9 years STANDARD_DEVIATION 9.2 • n=22 Participants	55.6 years STANDARD_DEVIATION 10.2 • n=8 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	79 Participants n=7 Participants	105 Participants n=5 Participants	82 Participants n=4 Participants	82 Participants n=21 Participants	83 Participants n=10 Participants	92 Participants n=115 Participants	92 Participants n=6 Participants	93 Participants n=6 Participants	91 Participants n=64 Participants	112 Participants n=17 Participants	102 Participants n=21 Participants	113 Participants n=22 Participants	1208 Participants n=8 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	145 Participants n=7 Participants	123 Participants n=5 Participants	141 Participants n=4 Participants	83 Participants n=21 Participants	85 Participants n=10 Participants	73 Participants n=115 Participants	125 Participants n=6 Participants	120 Participants n=6 Participants	116 Participants n=64 Participants	113 Participants n=17 Participants	114 Participants n=21 Participants	112 Participants n=22 Participants	1492 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF:Last observation carried forward)

Change from baseline in HbA1c after 52 weeks

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment	-0.70 % of HbA1c Standard Error 0.05	-0.82 % of HbA1c Standard Error 0.05	0.09 % of HbA1c Standard Error 0.05	-0.58 % of HbA1c Standard Error 0.05	-0.63 % of HbA1c Standard Error 0.07	-0.71 % of HbA1c Standard Error 0.07	-0.03 % of HbA1c Standard Error 0.07	-0.69 % of HbA1c Standard Error 0.05	-0.76 % of HbA1c Standard Error 0.05	-0.07 % of HbA1c Standard Error 0.05	-0.78 % of HbA1c Standard Error 0.05	-0.74 % of HbA1c Standard Error 0.05	-0.04 % of HbA1c Standard Error 0.05

PRIMARY outcome

Timeframe: Baseline and 76 weeks

Change from baseline in HbA1c after 76 weeks

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment	-0.65 % of HbA1c Standard Deviation 0.06	-0.76 % of HbA1c Standard Deviation 0.06	0.13 % of HbA1c Standard Deviation 0.06	-0.53 % of HbA1c Standard Deviation 0.06	-0.61 % of HbA1c Standard Deviation 0.07	-0.70 % of HbA1c Standard Deviation 0.07	-0.01 % of HbA1c Standard Deviation 0.07	-0.62 % of HbA1c Standard Deviation 0.05	-0.74 % of HbA1c Standard Deviation 0.05	-0.01 % of HbA1c Standard Deviation 0.05	-0.74 % of HbA1c Standard Deviation 0.06	-0.72 % of HbA1c Standard Deviation 0.06	-0.03 % of HbA1c Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Change from baseline in HbA1c (%) after 76 weeks using MMRM approach

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=132 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=132 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=65 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=108 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=71 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=78 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=31 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=130 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=118 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=70 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=110 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=103 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=76 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment	-0.70 % of HbA1c Standard Error 0.07	-0.77 % of HbA1c Standard Error 0.07	0.13 % of HbA1c Standard Error 0.08	-0.48 % of HbA1c Standard Error 0.07	-0.67 % of HbA1c Standard Error 0.09	-0.77 % of HbA1c Standard Error 0.08	-0.05 % of HbA1c Standard Error 0.12	-0.60 % of HbA1c Standard Error 0.06	-0.76 % of HbA1c Standard Error 0.07	0.07 % of HbA1c Standard Error 0.08	-0.75 % of HbA1c Standard Error 0.08	-0.75 % of HbA1c Standard Error 0.08	0.06 % of HbA1c Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)

Systolic blood pressure - change from baseline after 52 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	-4.9 mmHg Standard Error 0.8	-4.5 mmHg Standard Error 0.8	-1.6 mmHg Standard Error 0.8	-0.2 mmHg Standard Error 0.8	-1.8 mmHg Standard Error 0.9	-3.3 mmHg Standard Error 0.9	0.6 mmHg Standard Error 0.9	-3.6 mmHg Standard Error 0.7	-5.2 mmHg Standard Error 0.7	-0.7 mmHg Standard Error 0.7	-3.1 mmHg Standard Error 0.7	-2.7 mmHg Standard Error 0.7	-0.2 mmHg Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Systolic blood pressure - change from baseline after 76 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	-4.1 mmHg Standard Error 0.8	-4.2 mmHg Standard Error 0.8	-0.7 mmHg Standard Error 0.8	-0.3 mmHg Standard Error 0.8	-1.7 mmHg Standard Error 0.9	-3.4 mmHg Standard Error 0.9	0.3 mmHg Standard Error 0.9	-5.2 mmHg Standard Error 0.8	-4.5 mmHg Standard Error 0.8	-0.8 mmHg Standard Error 0.8	-3.8 mmHg Standard Error 0.7	-3.7 mmHg Standard Error 0.7	-1.6 mmHg Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF

Diastolic blood pressure - change from baseline after 52 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	-1.3 mmHg Standard Error 0.5	-1.9 mmHg Standard Error 0.5	-0.2 mmHg Standard Error 0.5	-0.3 mmHg Standard Error 0.5	-1.6 mmHg Standard Error 0.5	-2.2 mmHg Standard Error 0.5	0.4 mmHg Standard Error 0.5	-2.2 mmHg Standard Error 0.5	-2.1 mmHg Standard Error 0.5	-0.4 mmHg Standard Error 0.5	-1.7 mmHg Standard Error 0.5	-1.6 mmHg Standard Error 0.5	-1.0 mmHg Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Diastolic blood pressure - change from baseline after 76 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	-1.6 mmHg Standard Error 0.5	-1.6 mmHg Standard Error 0.5	-0.6 mmHg Standard Error 0.5	-0.1 mmHg Standard Error 0.5	-1.3 mmHg Standard Error 0.5	-2.0 mmHg Standard Error 0.5	0.2 mmHg Standard Error 0.5	-2.5 mmHg Standard Error 0.5	-1.9 mmHg Standard Error 0.5	-0.5 mmHg Standard Error 0.5	-2.6 mmHg Standard Error 0.5	-2.3 mmHg Standard Error 0.5	-1.4 mmHg Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF

Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment	-2.70 kg Standard Error 0.19	-2.61 kg Standard Error 0.19	-0.48 kg Standard Error 0.19	0.14 kg Standard Error 0.19	-1.50 kg Standard Error 0.24	-1.40 kg Standard Error 0.24	0.59 kg Standard Error 0.24	-2.27 kg Standard Error 0.19	-2.84 kg Standard Error 0.19	-0.54 kg Standard Error 0.20	-2.28 kg Standard Error 0.18	-2.32 kg Standard Error 0.19	-0.31 kg Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=217 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment	-2.24 kg Standard Error 0.20	-2.45 kg Standard Error 0.20	-0.43 kg Standard Error 0.20	0.10 kg Standard Error 0.20	-1.47 kg Standard Error 0.26	-1.21 kg Standard Error 0.26	0.50 kg Standard Error 0.26	-2.39 kg Standard Error 0.21	-2.65 kg Standard Error 0.22	-0.46 kg Standard Error 0.22	-2.44 kg Standard Error 0.19	-2.28 kg Standard Error 0.20	-0.63 kg Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF

Waist circumference (cm) - change from baseline after 52 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=221 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=163 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=167 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=222 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=215 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=219 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment	-2.0 cm Standard Error 0.4	-1.7 cm Standard Error 0.4	0.1 cm Standard Error 0.4	0.4 cm Standard Error 0.4	-1.5 cm Standard Error 0.4	-1.1 cm Standard Error 0.4	-0.1 cm Standard Error 0.4	-1.5 cm Standard Error 0.3	-2.0 cm Standard Error 0.3	-0.4 cm Standard Error 0.3	-1.5 cm Standard Error 0.3	-1.5 cm Standard Error 0.3	-0.2 cm Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Waist circumference (cm) - change from baseline after 76 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=224 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=228 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=221 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=163 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=167 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=222 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=215 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=219 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment	-1.5 cm Standard Error 0.4	-1.6 cm Standard Error 0.4	0.1 cm Standard Error 0.4	0.5 cm Standard Error 0.4	-1.4 cm Standard Error 0.4	-0.9 cm Standard Error 0.4	0.0 cm Standard Error 0.4	-1.8 cm Standard Error 0.3	-1.3 cm Standard Error 0.3	-0.2 cm Standard Error 0.3	-1.6 cm Standard Error 0.3	-1.4 cm Standard Error 0.3	-0.3 cm Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline and 52 weeks

Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF

Fasting plasma glucose - change from baseline after 52 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=226 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=163 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=215 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=224 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment	-18.9 mg/dL Standard Error 2.0	-23.9 mg/dL Standard Error 2.0	13.3 mg/dL Standard Error 2.0	-3.9 mg/dL Standard Error 2.0	-16.7 mg/dL Standard Error 2.8	-20.7 mg/dL Standard Error 2.8	10.3 mg/dL Standard Error 2.8	-16.7 mg/dL Standard Error 1.9	-19.7 mg/dL Standard Error 1.9	7.6 mg/dL Standard Error 2.0	-18.4 mg/dL Standard Error 2.1	-19.3 mg/dL Standard Error 2.1	9.4 mg/dL Standard Error 2.1

SECONDARY outcome

Timeframe: Baseline and 76 weeks

Fasting plasma glucose - change from baseline after 76 weeks of treatment

Outcome measures

Outcome measures
Measure	BI 10773 Low (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Drug Naive) n=226 Participants Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose	Sitagliptin 100mg (Drug Naive) n=223 Participants Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily	BI 10773 Low (Pioglitazone) n=163 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Pioglitazone) n=168 Participants Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Pioglitazone) n=165 Participants Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin) n=216 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily	BI 10773 High (Metformin) n=213 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin) n=207 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose	BI 10773 Low (Metformin+Sulfonylurea) n=225 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose	BI 10773 High (Metformin+Sulfonylurea) n=215 Participants Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose	Placebo (Metformin+Sulfonylurea) n=224 Participants Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment	-17.2 mg/dL Standard Error 2.1	-20.4 mg/dL Standard Error 2.1	14.4 mg/dL Standard Error 2.1	-1.8 mg/dL Standard Error 2.1	-13.9 mg/dL Standard Error 2.9	-18.0 mg/dL Standard Error 2.9	9.4 mg/dL Standard Error 2.9	-14.5 mg/dL Standard Error 2.0	-20.9 mg/dL Standard Error 2.0	10.5 mg/dL Standard Error 2.0	-19.5 mg/dL Standard Error 2.2	-20.4 mg/dL Standard Error 2.2	11.4 mg/dL Standard Error 2.2

Adverse Events

Empagliflozin 10 mg (Drug Naive)

Serious events: 23 serious events

Other events: 134 other events

Deaths: 0 deaths

Empagliflozin 25 mg (Drug Naive)

Serious events: 25 serious events

Other events: 110 other events

Deaths: 0 deaths

Placebo (Drug Naive)

Serious events: 16 serious events

Other events: 92 other events

Deaths: 0 deaths

Sitagliptin 100mg (Drug Naive)

Serious events: 18 serious events

Other events: 116 other events

Deaths: 0 deaths

Empagliflozin 10 mg (Pioglitazone)

Serious events: 11 serious events

Other events: 110 other events

Deaths: 0 deaths

Empagliflozin 25 mg (Pioglitazone)

Serious events: 13 serious events

Other events: 96 other events

Deaths: 0 deaths

Placebo (Pioglitazone)

Serious events: 15 serious events

Other events: 107 other events

Deaths: 0 deaths

Empagliflozin 10 mg (Metformin)

Serious events: 24 serious events

Other events: 122 other events

Deaths: 0 deaths

Empagliflozin 25 mg (Metformin)

Serious events: 19 serious events

Other events: 113 other events

Deaths: 0 deaths

Placebo (Metformin)

Serious events: 17 serious events

Other events: 106 other events

Deaths: 0 deaths

Empagliflozin 10 mg (Metformin+Sulfonylurea)

Serious events: 31 serious events

Other events: 146 other events

Deaths: 0 deaths

Empagliflozin 25 mg (Metformin+Sulfonylurea)

Serious events: 29 serious events

Other events: 147 other events

Deaths: 0 deaths

Placebo (Metformin+Sulfonylurea)

Serious events: 24 serious events

Other events: 142 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Empagliflozin 10 mg (Drug Naive) n=229 participants at risk Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Drug Naive) n=224 participants at risk Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Drug Naive) n=223 participants at risk Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Sitagliptin 100mg (Drug Naive) n=223 participants at risk Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100mg: Sitagliptin once daily	Empagliflozin 10 mg (Pioglitazone) n=165 participants at risk Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Pioglitazone) n=165 participants at risk Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Pioglitazone) n=168 participants at risk Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin) n=206 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	Empagliflozin 25 mg (Metformin) n=217 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin) n=214 participants at risk Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin+Sulfonylurea) n=225 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Metformin+Sulfonylurea) n=224 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin+Sulfonylurea) n=217 participants at risk Patients rolled over from 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
Infections and infestations Cellulitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.2% 2/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Gastroenteritis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Pneumonia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Urinary tract infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Amoebic colitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Cervicitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Dengue fever	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Pseudomonas infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Pyelonephritis acute	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Septic shock	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Infected skin ulcer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Urosepsis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Anal abscess	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Appendicitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Gangrene	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Herpes zoster	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Sepsis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Subcutaneous abscess	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Atypical pneumonia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Cytomegalovirus infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Genital infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Herpes virus infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Listeria sepsis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Peritonitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Pulmonary tuberculosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Salmonellosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Schistosomiasis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Upper respiratory tract infection	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Immune system disorders Hypersensitivity	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Endocrine disorders Empty sella syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Endocrine disorders Goitre	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Endocrine disorders Hyperparathyroidism	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Dehydration	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hyperglycaemia	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hyperlipidaemia	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Psychiatric disorders Stress	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Cerebral infarction	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Cerebrovascular accident	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Brain stem infarction	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Carotid artery stenosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Presyncope	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Brain stem stroke	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Carotid artery disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Cerebral ischaemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Diabetic neuropathy	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Dizziness	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Lacunar infarction	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Radiculitis brachial	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Syncope	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Transient ischaemic attack	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Trigeminal neuralgia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Convulsion	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Intercostal neuralgia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Ischaemic stroke	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Sciatica	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Subarachnoid haemorrhage	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Vascular headache	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Diabetic retinopathy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Cataract	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Dacryostenosis acquired	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Glaucoma	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Lens dislocation	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Retinal detachment	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Retinal vein occlusion	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Eye disorders Vitreous haemorrhage	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Ear and labyrinth disorders Vertigo positional	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Ear and labyrinth disorders Tinnitus	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Ear and labyrinth disorders Vertigo	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Ear and labyrinth disorders Meniere's disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Coronary artery disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.97% 2/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Acute myocardial infarction	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Angina pectoris	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Acute coronary syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Angina unstable	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Atrial fibrillation	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Atrial flutter	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Myocardial ischaemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Cardiac failure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Cardiac failure congestive	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Myocardial infarction	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Prinzmetal angina	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Aortic valve stenosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Stress cardiomyopathy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Ventricular tachycardia	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Cardiogenic shock	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Left ventricular failure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Cardiac disorders Acute left ventricular failure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Femoral artery occlusion	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Haematoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Vascular calcification	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Vascular occlusion	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Deep vein thrombosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Hypertension	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Ischaemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Arterial occlusive disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Venous occlusion	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Asthma	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Upper airway resistance syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Gastritis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Haemorrhoids	0.87% 2/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Anal fissure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Constipation	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Oesophageal rupture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Gastric polyps	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Gastric ulcer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Inguinal hernia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Nausea	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Vomiting	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Abdominal hernia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Faecaloma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Large intestine polyp	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Cholecystitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Cholecystitis acute	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Liver injury	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Cholelithiasis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Liver disorder	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Hepatobiliary disorders Jaundice	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.87% 2/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.97% 2/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Back pain	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Osteoarthropathy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Plica syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Nephrolithiasis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.97% 2/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Renal failure acute	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Dysuria	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Hypotonic urinary bladder	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Polyuria	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Renal and urinary disorders Renal failure	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Reproductive system and breast disorders Breast mass	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Reproductive system and breast disorders Menorrhagia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Congenital, familial and genetic disorders Gilbert's syndrome	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Congenital, familial and genetic disorders Phimosis	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Congenital, familial and genetic disorders Syringomyelia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Chest pain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Death	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Chest discomfort	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Non-cardiac chest pain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Hernia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Impaired healing	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
General disorders Sudden death	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Investigations Haemoglobin decreased	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Investigations Blood creatine phosphokinase increased	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Investigations Blood creatinine increased	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Investigations Smear cervix abnormal	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Fall	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Injury	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.60% 1/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.61% 1/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.46% 1/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Tendon rupture	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Animal bite	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Neck injury	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Surgical and medical procedures Knee arthroplasty	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.47% 1/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Surgical and medical procedures Hip arthroplasty	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Surgical and medical procedures Photocoagulation	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Surgical and medical procedures Vitrectomy	0.44% 1/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Surgical and medical procedures Leg amputation	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.

Other adverse events

Other adverse events
Measure	Empagliflozin 10 mg (Drug Naive) n=229 participants at risk Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Drug Naive) n=224 participants at risk Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Drug Naive) n=223 participants at risk Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	Sitagliptin 100mg (Drug Naive) n=223 participants at risk Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100mg: Sitagliptin once daily	Empagliflozin 10 mg (Pioglitazone) n=165 participants at risk Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Pioglitazone) n=165 participants at risk Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Pioglitazone) n=168 participants at risk Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin) n=206 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	Empagliflozin 25 mg (Metformin) n=217 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin) n=214 participants at risk Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 10 mg (Metformin+Sulfonylurea) n=225 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	Empagliflozin 25 mg (Metformin+Sulfonylurea) n=224 participants at risk Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	Placebo (Metformin+Sulfonylurea) n=217 participants at risk Patients rolled over from 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
Infections and infestations Urinary tract infection	9.2% 21/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.9% 20/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.8% 13/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.1% 18/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	20.0% 33/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	17.6% 29/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	19.6% 33/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	11.2% 23/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	11.5% 25/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.4% 18/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	12.4% 28/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	14.7% 33/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	15.2% 33/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Nasopharyngitis	11.8% 27/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	14.3% 32/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	11.2% 25/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	12.1% 27/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 7/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.1% 10/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.4% 9/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	18.9% 39/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	16.6% 36/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	13.6% 29/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	10.7% 24/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	16.1% 36/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	15.7% 34/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Upper respiratory tract infection	5.2% 12/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.6% 17/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.2% 16/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.5% 19/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.7% 11/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 9/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.9% 15/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.3% 17/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.2% 7/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	9.8% 21/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	10.7% 24/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.0% 18/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	9.7% 21/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Bronchitis	4.4% 10/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 11/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.4% 12/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.2% 2/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.0% 5/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.9% 8/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 8/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.4% 12/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.7% 8/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Infections and infestations Influenza	3.9% 9/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 5/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.1% 11/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Blood and lymphatic system disorders Anaemia	3.5% 8/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.9% 13/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 7/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.5% 11/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 5/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.4% 3/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.2% 5/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hyperglycaemia	27.5% 63/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.9% 20/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 11/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	12.6% 28/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	29.7% 49/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	16.4% 27/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	13.7% 23/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	27.2% 56/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	11.5% 25/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.5% 14/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	26.2% 59/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	10.7% 24/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	12.0% 26/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hypoglycaemia	1.3% 3/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.8% 8/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 7/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.9% 8/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.9% 15/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.7% 10/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	17.8% 40/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	23.7% 53/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	21.2% 46/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Dyslipidaemia	6.6% 15/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.1% 16/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.3% 14/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.3% 14/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	15.8% 26/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	13.9% 23/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	12.5% 21/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.4% 7/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.4% 16/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.7% 8/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.2% 5/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.2% 5/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.3% 5/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 3/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 9/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 7/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.49% 1/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.44% 1/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.00% 0/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.92% 2/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Dizziness	2.6% 6/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 6/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 6/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.3% 14/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.9% 6/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.3% 5/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.9% 4/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.1% 16/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.8% 13/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.8% 17/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Nervous system disorders Headache	3.9% 9/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.5% 10/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.2% 5/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.8% 8/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.1% 10/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.7% 13/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.4% 7/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.3% 7/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.8% 13/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	7.6% 17/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.6% 10/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Vascular disorders Hypertension	5.2% 12/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 11/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.2% 5/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.3% 14/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	9.7% 16/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 6/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 3/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.9% 6/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.2% 7/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.1% 11/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.89% 2/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.4% 3/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 6/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.0% 9/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.3% 3/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 6/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 3/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.4% 7/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.3% 5/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.3% 7/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.3% 3/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.8% 13/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Dyspepsia	0.87% 2/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.90% 2/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.2% 2/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.1% 10/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.97% 2/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.4% 3/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.3% 3/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Gastrointestinal disorders Diarrhoea	3.9% 9/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.4% 12/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 8/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.0% 5/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.6% 6/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 4/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 10/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.6% 10/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 9/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.5% 10/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.2% 7/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Back pain	4.8% 11/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	8.1% 18/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 9/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 9/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.2% 7/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 10/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.1% 9/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.1% 11/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 11/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.7% 15/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 12/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 11/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.0% 9/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.5% 10/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.1% 7/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.5% 9/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.1% 10/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	6.0% 10/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.4% 5/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.2% 7/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.3% 7/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 4/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.9% 11/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	3.7% 8/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.
Investigations Glycosylated haemoglobin increased	3.9% 9/229 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.5% 10/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.45% 1/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/223 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.8% 8/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.8% 3/165 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	1.2% 2/168 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	4.4% 9/206 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.8% 6/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	0.93% 2/214 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.3% 12/225 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	2.7% 6/224 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.	5.1% 11/217 • From signing of the informed consent until 7 days (inclusive) after last treatment For all safety analyses (except drug-related AEs), patients are assigned to the treatment group "as treated" at inclusion (if a patient erroneously receives the wrong trial drug, the patient is analysed as per the first treatment received). For drug-related AEs, patients are assigned to the actual treatment at onset of AE.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER