Trial Outcomes & Findings for EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) (NCT NCT03057951)

NCT ID: NCT03057951

Last Updated: 2022-06-06

Results Overview

Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 5988 participants
• Primary outcome timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.
• Results posted on: 2022-06-06

Participant Flow

A randomised, double-blind trial to demonstrate superiority of empagliflozin versus placebo in patients with symptomatic, chronic heart failure and preserved left ventricular ejection fraction (LVEF>40%) under stable treatment of heart failure symptoms.

Patients were included in the trial after they had signed the informed consent form (ICF). Patients who met all of the inclusion and none of the exclusion criteria were to be included in the trial. All patients were informed that they were free to withdraw their consent at any time during the trial without penalty or prejudice.

Participant milestones

Measure	Placebo 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Overall Study STARTED	2991	2997
Overall Study Treated	2989	2996
Overall Study COMPLETED	2046	2051
Overall Study NOT COMPLETED	945	946

Reasons for withdrawal

Measure	Placebo 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Overall Study Adverse Event	553	575
Overall Study Protocol Violation	30	24
Overall Study Lost to Follow-up	6	16
Overall Study Patient refusal to continue, not due to AE	304	284
Overall Study Study drug stopped, reason missing	6	1
Overall Study Medical advice	6	2
Overall Study Due to Covid-19 Pandemic	2	8
Overall Study Investigator decision	2	0
Overall Study Patient decision	5	2
Overall Study Not attending study visits	3	0
Overall Study Patient moved away	3	4
Overall Study Other reason than stated above	23	29
Overall Study Not treated	2	1

Baseline Characteristics

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

Baseline characteristics by cohort

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	Total n=5988 Participants Total of all reporting groups
Age, Continuous	71.9 Years STANDARD_DEVIATION 9.6 • n=5 Participants	71.8 Years STANDARD_DEVIATION 9.3 • n=7 Participants	71.9 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	1338 Participants n=5 Participants	1338 Participants n=7 Participants	2676 Participants n=5 Participants
Sex: Female, Male Male	1653 Participants n=5 Participants	1659 Participants n=7 Participants	3312 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	754 Participants n=5 Participants	770 Participants n=7 Participants	1524 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2236 Participants n=5 Participants	2227 Participants n=7 Participants	4463 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	104 Participants n=5 Participants	90 Participants n=7 Participants	194 Participants n=5 Participants
Race (NIH/OMB) Asian	411 Participants n=5 Participants	413 Participants n=7 Participants	824 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Black or African American	125 Participants n=5 Participants	133 Participants n=7 Participants	258 Participants n=5 Participants
Race (NIH/OMB) White	2256 Participants n=5 Participants	2286 Participants n=7 Participants	4542 Participants n=5 Participants
Race (NIH/OMB) More than one race	75 Participants n=5 Participants	60 Participants n=7 Participants	135 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:

Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].

Time at risk [years] = Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)	8.67 Patients with event/100 pt-yrs at risk Interval 7.94 to 9.44	6.86 Patients with event/100 pt-yrs at risk Interval 6.22 to 7.54

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)	541 HHF events	407 HHF events

SECONDARY outcome

Timeframe: At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.

Population: Only patients included in the treated set (TS) and with available data for this endpoint.

Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline.

Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.

Timepoints after baseline were included in calculation of slope of change from baseline.

The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".

Outcome measures

Measure	Placebo n=2911 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2925 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
eGFR (CKD-EPI) cr Slope of Change From Baseline	-2.616 mL/min/ 1.73 meters squared/year Standard Deviation 0.108	-1.253 mL/min/ 1.73 meters squared/year Standard Deviation 0.108

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.

Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.

Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR <15 mL/min/1.73 m^2 for patients with baseline eGFR ≥30 mL/min/1.73 m^2, or eGFR <10 mL/min/1.73 m^2 for patients with baseline eGFR <30 mL/min/1.73 m^2.

The incidence rate per 100 patient years (100 * number of patients with event / time at risk [years]) is reported. Time at risk [year] is calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Abbreviation:

Patient-years (pt-yrs).

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr	2.23 Patients with event /100 pt-yrs at risk Interval 1.84 to 2.66	2.13 Patients with event /100 pt-yrs at risk Interval 1.74 to 2.54

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:

Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].

Time at risk [years] = Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)	5.97 Patients with event /100 pt-yrs at risk Interval 5.37 to 6.62	4.28 Patients with event /100 pt-yrs at risk Interval 3.78 to 4.82

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:

Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].

Time at risk [years] = Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to Adjudicated Cardiovascular (CV) Death	3.81 Patients with event /100 pt-yrs at risk Interval 3.35 to 4.31	3.42 Patients with event /100 pt-yrs at risk Interval 2.98 to 3.89

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:

Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].

Time at risk [years] = Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to All-cause Mortality	6.67 Patients with event /100 pt-yrs at risk Interval 6.05 to 7.32	6.60 Patients with event /100 pt-yrs at risk Interval 5.98 to 7.24

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, to 1403 days.

Population: Randomised Set (RS), including all randomised patients and with available data for this endpoint.

Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM.

Pre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and <6.5%.

The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:

Incidence rate per 100 pt-yrs = 100 * number of patients with event / time at risk [years].

Time at risk [years] = Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Outcome measures

Measure	Placebo n=979 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=1001 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM	7.39 Patients with event /100 pt-yrs at risk Interval 6.21 to 8.68	6.12 Patients with event /100 pt-yrs at risk Interval 5.07 to 7.26

SECONDARY outcome

Timeframe: At baseline and at week 12, week 32 and week 52.

Population: Only Patients included in the treated set (TS) including values obtained on treatment. The number of patients analysed displays the number of patients with available data at the timepoint of interests.

The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

For patients who died, a worst score (score of 0) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.

Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.

Outcome measures

Measure	Placebo n=2335 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2333 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52	3.18 Score on a scale Standard Error 0.31	4.51 Score on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: From randomization until completion of the planned treatment phase, up to 1403 days.

Population: Randomised Set (RS), including all randomised patients.

Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.

Outcome measures

Measure	Placebo n=2991 Participants 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2997 Participants 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Occurrence of All-cause Hospitalisation (First and Recurrent)	2769 Events of all-cause hospitialisations	2566 Events of all-cause hospitialisations

Adverse Events

Placebo

Serious events: 1543 serious events

Other events: 1274 other events

Deaths: 427 deaths

10 mg Empagliflozin

Serious events: 1436 serious events

Other events: 1191 other events

Deaths: 422 deaths

Serious adverse events

Measure	Placebo n=2989 participants at risk 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2996 participants at risk 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Blood and lymphatic system disorders Anaemia	1.0% 30/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.63% 19/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Anaemia macrocytic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Anaemia megaloblastic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Blood loss anaemia	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Coagulopathy	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Hypochromic anaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Immune thrombocytopenia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Microcytic anaemia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Normocytic anaemia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Pancytopenia	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Splenic infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Acute coronary syndrome	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Acute left ventricular failure	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Acute myocardial infarction	1.6% 48/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.7% 50/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Angina pectoris	0.77% 23/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.93% 28/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Angina unstable	0.77% 23/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.87% 26/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Aortic valve incompetence	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Aortic valve stenosis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Arrhythmia	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Arrhythmia supraventricular	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrial fibrillation	2.7% 80/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	3.1% 92/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrial flutter	0.70% 21/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrial tachycardia	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrial thrombosis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrioventricular block	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrioventricular block complete	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.37% 11/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrioventricular block second degree	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Bradyarrhythmia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Bradycardia	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Bundle branch block left	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Bundle branch block right	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac amyloidosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac arrest	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.40% 12/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac failure	19.9% 594/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	15.0% 448/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac failure acute	0.97% 29/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.40% 12/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac failure chronic	1.0% 30/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.83% 25/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac failure congestive	2.2% 66/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.9% 57/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac sarcoidosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardio-respiratory arrest	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiogenic shock	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiopulmonary failure	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiorenal syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Cardiovascular disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Chronic left ventricular failure	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Chronotropic incompetence	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Coronary artery disease	1.1% 32/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.73% 22/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Coronary artery insufficiency	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Coronary artery occlusion	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Coronary artery stenosis	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ischaemic cardiomyopathy	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Left ventricular dysfunction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Left ventricular failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Left ventricular hypertrophy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Mitral valve disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Mitral valve incompetence	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Mitral valve stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Myocardial infarction	0.90% 27/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.2% 37/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Myocardial ischaemia	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Myocardial necrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Myocarditis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Palpitations	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Pericardial effusion	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Prinzmetal angina	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Pulseless electrical activity	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Right ventricular failure	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Silent myocardial infarction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Sinoatrial block	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Sinus arrest	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Sinus bradycardia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Sinus node dysfunction	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Stress cardiomyopathy	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Supraventricular tachyarrhythmia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Supraventricular tachycardia	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Tachyarrhythmia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Torsade de pointes	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Tricuspid valve incompetence	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular arrhythmia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular dyskinesia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular extrasystoles	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular fibrillation	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Ventricular tachycardia	0.74% 22/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.73% 22/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Atrial septal defect	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Buried penis syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Phimosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Talipes	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Deafness	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Deafness bilateral	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Deafness neurosensory	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Deafness unilateral	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Hypoacusis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Mixed deafness	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Sudden hearing loss	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Tinnitus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Vertigo	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Vertigo positional	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Adrenal insufficiency	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Basedow's disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Goitre	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Hyperplasia adrenal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Hyperthyroidism	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Pituitary apoplexy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Endocrine disorders Secondary adrenocortical insufficiency	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Amaurosis fugax	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Blindness transient	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Cataract	0.33% 10/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.33% 10/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Cataract nuclear	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Conjunctival disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Diabetic retinopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Eyelid ptosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Glaucoma	0.33% 10/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Macular degeneration	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Macular fibrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Macular hole	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Macular ischaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Neovascular age-related macular degeneration	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Normal tension glaucoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Open angle glaucoma	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Optic ischaemic neuropathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal artery embolism	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal artery occlusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal detachment	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal ischaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal tear	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Retinal vein occlusion	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Visual acuity reduced	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Eye disorders Vitreous haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Abdominal hernia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Abdominal mass	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain lower	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain upper	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Acute abdomen	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Ascites	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Chronic gastritis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Colitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Colitis ulcerative	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Constipation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diaphragmatic hernia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diarrhoea	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diverticular perforation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diverticulum	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Duodenitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Dyspepsia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Dysphagia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Enteritis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Enterocolitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Faecal vomiting	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastric haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastric polyps	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastric ulcer	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastritis	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastritis erosive	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.57% 17/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal polyp	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrointestinal ulcer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Haematochezia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Haemorrhagic ascites	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Haemorrhoids	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Hiatus hernia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Ileus	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Ileus paralytic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Incarcerated inguinal hernia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Incarcerated umbilical hernia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Inguinal hernia	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal angina	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal obstruction	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal perforation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal polyp	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intestinal strangulation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Large intestinal ulcer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Large intestine perforation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Large intestine polyp	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Mechanical ileus	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Melaena	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Mesenteric artery embolism	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Mesenteric artery stenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Nausea	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Obstructive pancreatitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophageal achalasia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophageal haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophageal rupture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Oesophagitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pancreatic disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pancreatic failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis acute	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis chronic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Peptic ulcer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Rectal haemorrhage	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Rectal prolapse	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Rectal ulcer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Retroperitoneal fibrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Salivary gland calculus	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Small intestinal haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Small intestinal obstruction	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Small intestinal stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Stomach mass	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Subacute pancreatitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Subileus	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Umbilical hernia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Volvulus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Gastrointestinal disorders Vomiting	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Accidental death	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Asthenia	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Cardiac death	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Chest discomfort	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Chest pain	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Death	1.3% 38/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.9% 56/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Discomfort	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Drowning	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Fatigue	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Fibrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Gait disturbance	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders General physical health deterioration	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Hernia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Hyperthermia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Hypothermia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Impaired healing	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Inflammation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Injection site phlebitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Malaise	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Medical device site oedema	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Multiple organ dysfunction syndrome	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Necrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Non-cardiac chest pain	0.54% 16/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Oedema peripheral	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Pacemaker generated arrhythmia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Physical deconditioning	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Pyrexia	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Stent-graft endoleak	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Strangulated hernia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Sudden cardiac death	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Sudden death	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.33% 10/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Systemic inflammatory response syndrome	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Vascular stent occlusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Vascular stent stenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
General disorders Vessel puncture site bruise	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Bile duct stone	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Biliary colic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Biliary obstruction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cardiac cirrhosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholangitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholangitis acute	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholecystitis	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholecystitis acute	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholelithiasis	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholestasis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Cholestatic liver injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Drug-induced liver injury	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatic cirrhosis	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatic failure	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatic function abnormal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatitis acute	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatitis cholestatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatorenal failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Hepatorenal syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Ischaemic hepatitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Jaundice	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Jaundice cholestatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Liver disorder	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Hepatobiliary disorders Liver injury	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Immune system disorders Allergy to vaccine	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Immune system disorders Amyloidosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Immune system disorders Anaphylactic reaction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Immune system disorders Corneal graft rejection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Abdominal infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Abdominal sepsis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Abscess	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Abscess limb	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Abscess neck	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Acinetobacter infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Acute sinusitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Anal abscess	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Appendicitis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Arthritis bacterial	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Atypical pneumonia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bacteraemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bacterial food poisoning	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bacterial sepsis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bacterial translocation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Breast abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Breast cellulitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bronchitis	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bronchitis bacterial	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bullous erysipelas	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Bursitis infective	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations COVID-19	1.6% 47/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.6% 49/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations COVID-19 pneumonia	0.57% 17/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.83% 25/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Cardiac valve abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Cellulitis	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.73% 22/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Cholangitis infective	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Cholecystitis infective	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Chronic sinusitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Clostridial sepsis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Clostridium difficile colitis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Clostridium difficile infection	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Colon gangrene	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Complicated appendicitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Coronavirus infection	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Cystitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Dengue fever	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Device related infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Device related sepsis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Diabetic foot infection	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Diabetic gangrene	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Diverticulitis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Dysentery	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Endocarditis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Endocarditis bacterial	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Endocarditis staphylococcal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Enteritis infectious	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Enterobacter sepsis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Enterococcal bacteraemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Epididymitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Erysipelas	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Escherichia sepsis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Fournier's gangrene	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Fungal oesophagitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gallbladder empyema	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gangrene	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gastroenteritis	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gastroenteritis norovirus	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gastroenteritis viral	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Gastrointestinal infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Haematoma infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Helicobacter gastritis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Helicobacter infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Hepatitis A	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Herpes zoster	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Herpes zoster infection neurological	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infected dermal cyst	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infected gouty tophus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infected skin ulcer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infectious pleural effusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Influenza	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Intervertebral discitis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Intestinal sepsis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Joint abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Klebsiella bacteraemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Klebsiella infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Labyrinthitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Large intestine infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Liver abscess	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Localised infection	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Lower respiratory tract infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Ludwig angina	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Lung abscess	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Mastoiditis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Meningitis bacterial	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Neurocysticercosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Orchitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Osteomyelitis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Osteomyelitis acute	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Parotid abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pathogen resistance	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Perineal abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Periodontitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Peritonitis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Peritonitis bacterial	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Peritonsillar abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Peritonsillitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Petrositis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pneumonia	4.0% 119/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	3.3% 100/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pneumonia bacterial	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pneumonia parainfluenzae viral	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pneumonia pneumococcal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pneumonia viral	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Postoperative abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Postoperative wound infection	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Prostatitis Escherichia coli	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pseudomembranous colitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pulmonary sepsis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pulmonary tuberculosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pyelonephritis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Pyelonephritis acute	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Respiratory tract infection	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Sepsis	0.70% 21/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.87% 26/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Septic shock	0.37% 11/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.37% 11/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Severe acute respiratory syndrome	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Severe fever with thrombocytopenia syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Small intestine gangrene	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Soft tissue infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Staphylococcal bacteraemia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Staphylococcal sepsis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Staphylococcal skin infection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Streptococcal bacteraemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Streptococcal infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Streptococcal sepsis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Superinfection	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Suspected COVID-19	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Systemic bacterial infection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Systemic candida	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Testicular abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Tooth abscess	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Tracheobronchitis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Upper respiratory tract infection	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Urinary tract infection	0.94% 28/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.2% 36/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Urosepsis	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.40% 12/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Viral upper respiratory tract infection	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Wound abscess	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Wound infection	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Wound infection staphylococcal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Wound sepsis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Animal bite	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Ankle fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Back injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Brain contusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Burns second degree	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Bursa injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Chest injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Clavicle fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Concussion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Contusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Corneal graft failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Coronary artery restenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Craniocerebral injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Craniofacial fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Cystitis radiation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Deafness traumatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Diffuse axonal injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Dural tear	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Epidural haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Fall	1.0% 30/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.0% 31/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Femoral neck fracture	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Femur fracture	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Forearm fracture	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Gastrointestinal injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Genital contusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Hand fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Head injury	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Heart injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Hip fracture	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.30% 9/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Humerus fracture	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Incision site haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebrospinal fluid leakage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Jaw fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Joint injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Limb injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Maisonneuve fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Multiple fractures	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Overdose	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Patella fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Pelvic fracture	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Periprosthetic fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Post procedural complication	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Post procedural inflammation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Postoperative delirium	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Postoperative ileus	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Postoperative renal failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Procedural pain	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Procedural shock	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Pulmonary contusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Radius fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Rib fracture	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Road traffic accident	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Skin injury	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Skin laceration	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Spinal fracture	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Sternal fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Subdural haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Toxicity to various agents	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Traumatic fracture	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Traumatic spinal cord compression	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Upper limb fracture	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Urethral injury	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Urethral stricture postoperative	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Alanine aminotransferase increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Anticoagulation drug level above therapeutic	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Anticoagulation drug level below therapeutic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Aspartate aminotransferase increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood creatine phosphokinase increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood creatinine increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood ketone body increased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood potassium increased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood pressure increased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Blood urine present	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Brain natriuretic peptide	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations C-reactive protein increased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Ejection fraction decreased	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Glomerular filtration rate decreased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Hepatic enzyme increased	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Liver function test abnormal	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Occult blood positive	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Prostatic specific antigen abnormal	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Transaminases increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Troponin increased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Investigations Weight decreased	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Cachexia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Decreased appetite	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Dehydration	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.50% 15/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetic complication	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.60% 18/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.37% 11/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Fluid imbalance	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Fluid overload	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Food intolerance	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Gout	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypercreatininaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.67% 20/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.40% 12/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypernatraemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.43% 13/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypokalaemia	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyponatraemia	0.33% 10/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypophagia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hypovolaemia	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Ketoacidosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Ketosis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Lactic acidosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Metabolic acidosis	0.37% 11/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Obesity	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Acquired claw toe	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Arthropathy	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Back pain	0.27% 8/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Costochondritis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Exostosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Fistula	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Groin pain	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Myopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.54% 16/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.37% 11/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteoporosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Pathological fracture	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Sacroiliac joint dysfunction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Sarcopenia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Scleroderma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Spinal pain	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Tendonitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Vertebral column mass	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal gland cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 32/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.57% 17/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of testis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal adenocarcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomangiopericytoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive papillary breast carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratinising squamous cell carcinoma of nasopharynx	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.33% 10/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal wall	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myxoid liposarcoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal sinus cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer stage I	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal tumour	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung metastatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma metastatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.37% 11/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.37% 11/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal adenoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer metastatic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.30% 9/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the parotid gland	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Altered state of consciousness	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Arachnoid cyst	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Brain compression	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Brain injury	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Brain oedema	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Brain stem ischaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Brain stem stroke	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid arteriosclerosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid artery aneurysm	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid artery disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid artery dissection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid artery occlusion	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carotid artery stenosis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Central nervous system lesion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebellar haematoma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebellar infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral artery embolism	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral artery occlusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral atrophy	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral haematoma	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral haemorrhage	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral infarction	0.33% 10/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral ischaemia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebral small vessel ischaemic disease	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cerebrovascular accident	0.67% 20/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.70% 21/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cervical cord compression	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cervical radiculopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cognitive disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Coma	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Cranial nerve palsies multiple	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Dementia	0.33% 10/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Dementia Alzheimer's type	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Demyelination	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Disturbance in attention	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Dizziness	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Drop attacks	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Dysarthria	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Embolic cerebral infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Embolic stroke	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Encephalomalacia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Encephalopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Epilepsy	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Generalised tonic-clonic seizure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Haemorrhage intracranial	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Haemorrhagic stroke	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Haemorrhagic transformation stroke	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Headache	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hemiparesis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hemiplegia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hepatic encephalopathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hydrocephalus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hypoaesthesia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hypoglycaemic seizure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Intracranial aneurysm	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Ischaemic cerebral infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Ischaemic stroke	1.2% 35/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.4% 42/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Lacunar infarction	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Lacunar stroke	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Loss of consciousness	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Lumbar radiculopathy	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Migraine	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Nervous system disorder	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Neurological symptom	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Neuropathy peripheral	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Paraesthesia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Paraplegia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Parkinson's disease	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Parkinsonism	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Posterior cortical atrophy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Postresuscitation encephalopathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Presyncope	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Sciatica	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Seizure	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Senile dementia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Sensorimotor disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Speech disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Status epilepticus	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Subarachnoid haemorrhage	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Syncope	0.64% 19/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.77% 23/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Thalamus haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Thoracic radiculopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Toxic encephalopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Transient global amnesia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Transient ischaemic attack	0.70% 21/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.67% 20/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Tremor	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Vascular dementia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Vascular encephalopathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Vertebral artery stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Vertebral artery thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Device breakage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Device dislocation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Device failure	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Device leakage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Device malfunction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Product Issues Thrombosis in device	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Adjustment disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Anxiety	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Anxiety disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Bipolar I disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Bipolar disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Completed suicide	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Confusional state	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Delirium	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.30% 9/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Depression	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Disorientation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Insomnia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Nosophobia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Paranoia	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Psychiatric disorders Suicide attempt	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Acute kidney injury	3.6% 107/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	2.7% 81/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Bladder tamponade	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Calculus urinary	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Chronic kidney disease	0.84% 25/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.53% 16/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Cystitis haemorrhagic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders End stage renal disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Haematuria	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Hydronephrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Ketonuria	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Nephrolithiasis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Nephropathy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Nephropathy toxic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Nephrotic syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Neurogenic bladder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Pelvi-ureteric obstruction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Pollakiuria	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Postrenal failure	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Proteinuria	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal artery stenosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal colic	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal failure	0.70% 21/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.30% 9/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal impairment	1.4% 42/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	1.3% 38/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal injury	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal tubular necrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Ureterolithiasis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urethral caruncle	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urethral cyst	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urethral stenosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urinary bladder rupture	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urinary incontinence	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urinary retention	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Vesical fistula	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Acquired hydrocele	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Acquired phimosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Cervix disorder	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Prostatitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Uterine inflammation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Uterine polyp	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.23% 7/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.67% 20/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Aspiration	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Choking	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 37/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.77% 23/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Combined pulmonary fibrosis and emphysema	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.30% 9/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pleural thickening	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 11/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.17% 5/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.43% 13/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.50% 15/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Angioedema	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Diabetic foot	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.13% 4/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Paraneoplastic dermatomyositis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Pemphigoid	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Skin necrosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Skin ulcer	0.37% 11/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Surgical and medical procedures Heart valve replacement	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Surgical and medical procedures Hospitalisation	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Accelerated hypertension	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Angiodysplasia	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Aortic aneurysm	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Aortic aneurysm rupture	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Aortic dissection	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Aortic stenosis	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Aortic thrombosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Arterial occlusive disease	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Arteriosclerosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Bleeding varicose vein	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Circulatory collapse	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Cyanosis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Deep vein thrombosis	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Dry gangrene	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Embolism	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Essential hypertension	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Extremity necrosis	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Femoral artery aneurysm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Haematoma	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Haemorrhage	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Haemorrhagic infarction	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypertension	0.40% 12/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.27% 8/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypertensive crisis	1.1% 32/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.43% 13/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypertensive emergency	0.13% 4/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypertensive urgency	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.10% 3/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypotension	0.64% 19/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.87% 26/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypovolaemic shock	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Iliac artery dissection	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Iliac artery occlusion	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Intermittent claudication	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Malignant hypertension	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Orthostatic hypotension	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Penetrating aortic ulcer	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral arterial occlusive disease	0.54% 16/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.47% 14/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral artery aneurysm	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral artery occlusion	0.20% 6/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.20% 6/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral artery stenosis	0.10% 3/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral artery thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral embolism	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral ischaemia	0.17% 5/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.23% 7/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral vascular disorder	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Peripheral venous disease	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Phlebitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Phlebitis superficial	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Shock	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Shock haemorrhagic	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.07% 2/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Subclavian vein thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Thrombophlebitis	0.03% 1/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Thrombophlebitis superficial	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Thrombosis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Varicose vein	0.07% 2/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.00% 0/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Vasculitis	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Venous thrombosis limb	0.00% 0/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	0.03% 1/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.

Other adverse events

Measure	Placebo n=2989 participants at risk 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).	10 mg Empagliflozin n=2996 participants at risk 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Blood and lymphatic system disorders Anaemia	5.5% 164/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	4.0% 119/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Cardiac disorders Atrial fibrillation	5.2% 156/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	4.6% 137/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Infections and infestations Urinary tract infection	5.4% 160/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	6.9% 207/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Injury, poisoning and procedural complications Fall	6.5% 193/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	6.3% 189/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Diabetes mellitus	6.7% 200/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	4.6% 139/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperkalaemia	6.5% 194/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	5.7% 170/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Metabolism and nutrition disorders Hyperuricaemia	7.0% 208/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	4.4% 131/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Renal and urinary disorders Renal impairment	6.1% 181/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	5.9% 177/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypertension	8.3% 248/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	7.1% 212/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.
Vascular disorders Hypotension	5.9% 176/2989 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.	7.1% 212/2996 • [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. \[All-cause mortality\]: Randomised Set (RS), including all randomised patients. \[Serious AE and other AE\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.

Additional Information

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