Trial Outcomes & Findings for Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients (NCT NCT01422876)

NCT ID: NCT01422876

Last Updated: 2015-04-02

Results Overview

Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1405 participants
• Primary outcome timeframe: Baseline and 24 weeks
• Results posted on: 2015-04-02

Participant Flow

Of the 1405 patients enrolled and randomized the data for 42 randomized patients were excluded from all analyses due to serious non-compliance. Therefore, 1363 patients were included in the analyses.

Participant milestones

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 10 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Treatment Naive: Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Week 24 STARTED	137	136	141	140	132	137	136	135	134	135
Week 24 COMPLETED	131	133	136	132	125	131	130	128	128	125
Week 24 NOT COMPLETED	6	3	5	8	7	6	6	7	6	10
Week 52 STARTED	137	136	141	140	132	137	136	135	134	135
Week 52 COMPLETED	125	126	128	122	117	120	120	112	113	118
Week 52 NOT COMPLETED	12	10	13	18	15	17	16	23	21	17

Reasons for withdrawal

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 10 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Treatment Naive: Linagliptin 5 mg Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Week 24 Lost to Follow-up	1	1	2	4	2	0	1	3	3	4
Week 24 Consent withdrawn	5	1	3	4	5	6	5	4	3	6
Week 24 Death	0	1	0	0	0	0	0	0	0	0
Week 52 Lost to Follow-up	3	5	7	5	8	5	5	8	7	8
Week 52 Consent withdrawn	9	4	6	12	7	12	10	12	13	9
Week 52 Death	0	1	0	1	0	0	1	3	1	0

Baseline Characteristics

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Baseline characteristics by cohort

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. . Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=140 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=137 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=128 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 25 mg n=133 Participants Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Treatment Naive: Empagliflozin 10 mg n=132 Participants Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Treatment Naive: Linagliptin 5 mg n=133 Participants Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral	Total n=1341 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	56.2 years STANDARD_DEVIATION 10.3 • n=7 Participants	55.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	56.1 years STANDARD_DEVIATION 10.5 • n=4 Participants	56.2 years STANDARD_DEVIATION 10.0 • n=21 Participants	54.2 years STANDARD_DEVIATION 10.0 • n=10 Participants	55.2 years STANDARD_DEVIATION 9.8 • n=115 Participants	56.0 years STANDARD_DEVIATION 9.3 • n=6 Participants	53.9 years STANDARD_DEVIATION 10.5 • n=6 Participants	53.8 years STANDARD_DEVIATION 11.5 • n=64 Participants	55.4 years STANDARD_DEVIATION 10.2 • n=17 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	52 Participants n=7 Participants	75 Participants n=5 Participants	59 Participants n=4 Participants	64 Participants n=21 Participants	64 Participants n=10 Participants	62 Participants n=115 Participants	56 Participants n=6 Participants	68 Participants n=6 Participants	58 Participants n=64 Participants	620 Participants n=17 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	83 Participants n=7 Participants	65 Participants n=5 Participants	78 Participants n=4 Participants	64 Participants n=21 Participants	70 Participants n=10 Participants	73 Participants n=115 Participants	77 Participants n=6 Participants	64 Participants n=6 Participants	75 Participants n=64 Participants	721 Participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=140 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=137 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=128 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients	-1.19 % change from baseline Standard Error 0.06	-1.08 % change from baseline Standard Error 0.06	-0.62 % change from baseline Standard Error 0.06	-0.66 % change from baseline Standard Error 0.06	-0.70 % change from baseline Standard Error 0.06

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.

Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=132 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients	-1.08 % change from baseline Standard Error 0.07	-1.24 % change from baseline Standard Error 0.07	-0.95 % change from baseline Standard Error 0.07	-0.83 % change from baseline Standard Error 0.07	-0.67 % change from baseline Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=139 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=136 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=127 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients	-35.25 mg/dL change from baseline Standard Error 2.53	-32.18 mg/dL change from baseline Standard Error 2.52	-18.83 mg/dL change from baseline Standard Error 2.47	-20.84 mg/dL change from baseline Standard Error 2.50	-13.05 mg/dL change from baseline Standard Error 2.59

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=132 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients	-29.55 mg/dL change from baseline Standard Error 2.67	-28.21 mg/dL change from baseline Standard Error 2.66	-24.24 mg/dL change from baseline Standard Error 2.68	-22.39 mg/dL change from baseline Standard Error 2.69	-5.92 mg/dL change from baseline Standard Error 2.68

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Change from baseline in body weight for Metformin Background patients.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=140 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=137 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=128 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Body Weight for Metformin Background Patients	-2.99 kg change from baseline Standard Error 0.31	-2.60 kg change from baseline Standard Error 0.30	-3.18 kg change from baseline Standard Error 0.30	-2.53 kg change from baseline Standard Error 0.30	-0.69 kg change from baseline Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.

Change from baseline in body weight for Treatment Naive patients.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=134 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=135 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=132 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=133 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Change From Baseline in Body Weight for Treatment Naive Patients	-2.00 kg change from baseline Standard Error 0.36	-2.74 kg change from baseline Standard Error 0.36	-2.13 kg change from baseline Standard Error 0.36	-2.27 kg change from baseline Standard Error 0.37	-0.78 kg change from baseline Standard Error 0.36

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS- Metformin background patients randomised and treated who had a baseline (HbA1c\>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.

Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=123 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=128 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=132 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=125 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=119 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients	61.8 % of patients satisfying HbA1c <7.0% Interval 52.6 to 70.4	57.8 % of patients satisfying HbA1c <7.0% Interval 48.8 to 66.5	32.6 % of patients satisfying HbA1c <7.0% Interval 24.7 to 41.3	28.0 % of patients satisfying HbA1c <7.0% Interval 20.3 to 36.7	36.1 % of patients satisfying HbA1c <7.0% Interval 27.5 to 45.4

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS-treatment naive patients randomised and treated who had a baseline (HbA1c\>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.

Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.

Outcome measures

Measure	Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg n=121 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg n=122 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 25 mg n=118 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Metformin Background: Empagliflozin 10 mg n=121 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Metformin Background: Linagliptin 5 mg n=127 Participants Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients	55.4 % of patients satisfying HbA1c <7.0% Interval 46.1 to 64.4	62.3 % of patients satisfying HbA1c <7.0% Interval 53.1 to 70.9	41.5 % of patients satisfying HbA1c <7.0% Interval 32.5 to 51.0	38.8 % of patients satisfying HbA1c <7.0% Interval 30.1 to 48.1	32.3 % of patients satisfying HbA1c <7.0% Interval 24.3 to 41.2

Adverse Events

Empagliflozin 25 mg/Linagliptin 5 mg

Serious events: 12 serious events

Other events: 80 other events

Deaths: 0 deaths

Empagliflozin 10 mg/Linagliptin 5 mg

Serious events: 16 serious events

Other events: 86 other events

Deaths: 0 deaths

Empagliflozin 25 mg

Serious events: 19 serious events

Other events: 70 other events

Deaths: 0 deaths

Empagliflozin 10 mg

Serious events: 16 serious events

Other events: 83 other events

Deaths: 0 deaths

Linagliptin 5 mg

Serious events: 10 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	Empagliflozin 25 mg/Linagliptin 5 mg n=273 participants at risk Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Empagliflozin 10 mg/Linagliptin 5 mg n=272 participants at risk Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Empagliflozin 25 mg n=276 participants at risk Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Empagliflozin 10 mg n=275 participants at risk Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Linagliptin 5 mg n=267 participants at risk Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Infections and infestations Bacterial infection	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Cellulitis	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Cystitis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Diverticulitis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Encephalitis viral	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Meningitis tuberculous	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Peritonitis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Pneumonia viral	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Pyelonephritis acute	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Pyelonephritis chronic	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Tooth abscess	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Urinary tract infection	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Urosepsis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Metabolism and nutrition disorders Alkalosis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Angina pectoris	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Metabolism and nutrition disorders Dehydration	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Angina unstable	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Psychiatric disorders Confusional state	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Psychiatric disorders Mental status changes	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Transient ischaemic attack	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.73% 2/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Brain oedema	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Cerebral infarction	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Cerebrovascular accident	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Dementia Alzheimer's type	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Encephalopathy	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Haemorrhagic stroke	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Lethargy	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Syncope	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Acute coronary syndrome	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Coronary artery disease	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Coronary artery occlusion	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Hypertensive heart disease	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Myocardial infarction	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Palpitations	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Cardiac disorders Silent myocardial infarction	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Vascular disorders Hypotension	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Vascular disorders Varicose vein	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Abdominal adhesions	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Abdominal pain	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Colitis ischaemic	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Intestinal perforation	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Mechanical ileus	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Hepatobiliary disorders Cholelithiasis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.72% 2/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Hepatobiliary disorders Hepatic mass	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Musculoskeletal and connective tissue disorders Flank pain	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Renal and urinary disorders Calculus bladder	0.37% 1/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Renal and urinary disorders Calculus ureteric	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Renal and urinary disorders Hydronephrosis	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Renal and urinary disorders Renal colic	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Renal and urinary disorders Renal failure acute	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Reproductive system and breast disorders Ovarian cyst	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Reproductive system and breast disorders Rectocele	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
General disorders Chest pain	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.74% 2/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
General disorders Non-cardiac chest pain	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Investigations Troponin increased	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Chemical injury	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Seroma	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.37% 1/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Surgical and medical procedures Finger amputation	0.00% 0/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.36% 1/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	0.00% 0/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).

Other adverse events

Measure	Empagliflozin 25 mg/Linagliptin 5 mg n=273 participants at risk Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral	Empagliflozin 10 mg/Linagliptin 5 mg n=272 participants at risk Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral	Empagliflozin 25 mg n=276 participants at risk Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral	Empagliflozin 10 mg n=275 participants at risk Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral	Linagliptin 5 mg n=267 participants at risk Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Infections and infestations Urinary tract infection	9.9% 27/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	10.7% 29/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	9.1% 25/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	10.9% 30/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	10.1% 27/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Nasopharyngitis	6.6% 18/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	5.9% 16/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	3.6% 10/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	5.8% 16/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	7.5% 20/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Infections and infestations Upper respiratory tract infection	7.0% 19/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	7.0% 19/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	6.5% 18/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.7% 13/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	6.0% 16/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Metabolism and nutrition disorders Hyperglycaemia	2.9% 8/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	2.9% 8/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.3% 12/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.4% 12/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	9.0% 24/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Nervous system disorders Headache	5.9% 16/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	5.5% 15/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.7% 13/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	6.9% 19/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	9.0% 24/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 5/273 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	5.1% 14/272 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.7% 13/276 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	3.6% 10/275 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).	4.5% 12/267 • From first trial medication intake until 7 days after last drug intake during the 52-week study period One patient was randomized to treatment with Empa/Lina 25/5 but was treated with Empa 10 from the start of trial for 6 weeks. For efficacy, the patient was analyzed as randomized (Empa/Lina 25/5) and for safety the patient was analyzed as first medication taken (Empa 10).

Additional Information

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