Trial Outcomes & Findings for A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated (NCT NCT04107805)

Last Updated: 2024-02-22

Results Overview

Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

87 participants

Primary outcome timeframe

Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days.

Results posted on

2024-02-22

Participant Flow

This was a trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising oral doses of BI 1323495 versus placebo in healthy subjects, including an investigation of drug-drug interaction with microdose midazolam (double-blind, randomised, placebo-controlled \[within dose groups\] trial).

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo/Placebo + Midazolam This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single daily dose of 1.5 milliliter (mL) of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	10 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM Participants with at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Overall Study STARTED	22	9	5	9	6	9	9	9	9
Overall Study COMPLETED	22	9	5	8	6	8	9	9	8
Overall Study NOT COMPLETED	0	0	0	1	0	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Placebo + Midazolam This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single daily dose of 1.5 milliliter (mL) of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	10 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM Participants with at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Overall Study Adverse Event	0	0	0	1	0	1	0	0	1

Baseline Characteristics

A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Placebo + Midazolam n=22 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single daily dose of 1.5 milliliter (mL) of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	10 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=5 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants with at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	Total n=87 Participants Total of all reporting groups
Age, Continuous	34.1 Years STANDARD_DEVIATION 11.1 • n=5 Participants	44.3 Years STANDARD_DEVIATION 15.8 • n=7 Participants	36.4 Years STANDARD_DEVIATION 14.2 • n=5 Participants	43.3 Years STANDARD_DEVIATION 15.4 • n=4 Participants	41.2 Years STANDARD_DEVIATION 15.1 • n=21 Participants	44.4 Years STANDARD_DEVIATION 13.1 • n=8 Participants	33.7 Years STANDARD_DEVIATION 10.3 • n=8 Participants	29.9 Years STANDARD_DEVIATION 9.4 • n=24 Participants	35.3 Years STANDARD_DEVIATION 15.5 • n=42 Participants	37.4 Years STANDARD_DEVIATION 13.4 • n=42 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	32 Participants n=42 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	4 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	55 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=8 Participants	9 Participants n=8 Participants	9 Participants n=24 Participants	9 Participants n=42 Participants	87 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	9 Participants n=8 Participants	9 Participants n=24 Participants	9 Participants n=42 Participants	83 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days.

Population: Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.

Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=22 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=36 Participants This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=5 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Percentage of Participants With Treatment-emergent Drug-related Adverse Events (AEs)	4.5 percentage of participants	0 percentage of participants	22.2 percentage of participants	0 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	11.1 percentage of participants	22.2 percentage of participants	0 percentage of participants	44.4 percentage of participants

SECONDARY outcome

Timeframe: Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, and 12h after the first administration of BI 1323495 on Day 1.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed to only 1 PK parameter value for 1 period to the statistical assessment. Only participants with evaluable results for this PK parameter are reported.

Area under the concentration-time curve of BI 1323495 in plasma over a time interval of 12 h after administration of the first dose (AUC0-12) is reported.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=9 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=5 Participants This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=7 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=5 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over a Time Interval of 12 h After Administration of the First Dose (AUC0-12)	118 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 56.1	430 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 27.2	282 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 66.2	1310 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 29.1	702 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 48.6	982 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 76.2	784 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 81.7	NA hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation NA AUC0-12 could not be calculated due to low number of participants with valid AUC0-12 values.	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24 h after administration of BI 1323495 on Day 1.

Population: Pharmacokinetic (PK) parameter analysis set (PKS) of 120 mg BI qd EM arm: This set included all treated subjects of 120 mg BI 1323495 qd EM arm who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS of arm, even if he/she contributed to only 1 PK parameter value for 1 period to the statistical assessment. Only participants with evaluable results are reported.

Area under the concentration-time curve of BI 1323495 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) for the once daily (qd) dosing group is reported.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=7 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Only for Once Daily (qd) Dosing Group: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)	1550 hours nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 75.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 20 minutes (min), 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the first administration of BI 1323495 on Day 1. * Applicable only for the 120 mg BI 1323495 qd EM arm.

Maximum measured concentration of BI 1323495 in plasma after the first dose (Cmax) is reported.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=9 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=5 Participants This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=9 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Maximum Measured Concentration of BI 1323495 in Plasma After the First Dose (Cmax)	23.5 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 31.4	85.3 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 30.1	62.0 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 57.1	216 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 39.7	123 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 50.0	152 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 67.5	125 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 98.1	109 nanomol/Liter (nmol/L) Geometric Coefficient of Variation 77.8	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the last administration of BI 1323495 on Day 11. * Applicable only for the 120 mg BI 1323495 qd EM arm.

Area under the concentration-time curve of BI 1323495 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is reported. The dosing interval τ is not the same for all groups. The dosing interval is 12 hours (h) for the dose groups with a twice daily (bid) BI 1323495 administration and 24 h for the dose group with a once daily (qd) BI 1323495 administration.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=9 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=5 Participants This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=9 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)	237 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 60.8	738 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 22.8	475 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 86.2	2370 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 28.1	2490 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 59.4	2850 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 69.4	1960 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 55.9	2070 hours *nanomol/Liter (hnmol/L) Geometric Coefficient of Variation 41.5	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 20 min, 40 min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h and 24h* after the last drug administration of BI 1323495 on Day 11. * Applicable only for the 120 mg BI 1323495 qd EM arm.

Maximum measured concentration of BI 1323495 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is reported. The dosing interval τ is not the same for all groups. The dosing interval is 12 hours (h) for the dose groups with a twice daily (bid) BI 1323495 administration and 24 h for the dose group with a once daily (qd) BI 1323495 administration.

Outcome measures

Outcome measures
Measure	Placebo/Placebo+ Midazolam n=9 Participants This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=5 Participants This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=6 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=9 Participants Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=8 Participants Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)	37.5 nanomol/liter (nmol/L) Geometric Coefficient of Variation 49.6	109 nanomol/liter (nmol/L) Geometric Coefficient of Variation 27.7	64.4 nanomol/liter (nmol/L) Geometric Coefficient of Variation 78.7	300 nanomol/liter (nmol/L) Geometric Coefficient of Variation 32.6	281 nanomol/liter (nmol/L) Geometric Coefficient of Variation 48.0	362 nanomol/liter (nmol/L) Geometric Coefficient of Variation 77.7	164 nanomol/liter (nmol/L) Geometric Coefficient of Variation 48.7	265 nanomol/liter (nmol/L) Geometric Coefficient of Variation 46.0	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo/Placebo + Midazolam n=22 participants at risk This arm comprises placebo only treated participants and those participants who received placebo + midazolam. Placebo only treated participants were administered film-coated tablets of placebo matching BI 1323495 dosage and participants who received placebo + midazolam were administered film-coated tablets of placebo matching BI 1323495 dosage + a single daily dose of 1.5 milliliter (mL) of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast on Day -1 and on Day 11.	Midazolam Alone n=36 participants at risk This arm consisted of all participants of the arms "70 mg BI 1323495 bid + Midazolam EM", "120 mg BI 1323495 bid + Midazolam EM", "150 mg BI 1323495 bid + Midazolam EM" and 9 subjects of the arm "Placebo/Placebo + Midazolam" which were administered midazolam on Day -1 of the trial. The duration of this analysis phase was approximately 1 day (from Day -1 to first administration of BI 1323495 on Day 1).	10 mg BI 1323495 Bid EM n=9 participants at risk Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	10 mg BI 1323495 Bid PM n=5 participants at risk Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 10 milligram (mg) of BI 1323495 orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid EM n=9 participants at risk Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage=30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	30 mg BI 1323495 Bid PM n=6 participants at risk Participants carrying no functional allele of the UGT2B17 gene (poor metabolisers (PM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) three film-coated tablets of 10 milligram (mg) of BI 1323495 (total dosage = 30 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	70 mg BI 1323495 Bid + Midazolam EM n=9 participants at risk Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and one film-coated tablet of 50 mg of BI 1323495 (total dosage=70 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single dose of 1.5 ml of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 Bid + Midazolam EM n=9 participants at risk Participants with at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.	120 mg BI 1323495 qd EM n=9 participants at risk Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 11 once daily (qd) two film-coated tablets of 10 milligram (mg) and two film-coated tablets of 50 mg of BI 1323495 (total dosage=120 mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal.	150 mg BI 1323495 Bid + Midazolam EM n=9 participants at risk Participants carrying at least one functional allele of the UGT2B17 gene (extensive metabolisers (EM)) were administered from Day 1 to Day 10 twice daily (bid) and on Day 11 once daily (qd) one film-coated tablet of 150 milligram (mg) orally with 240 milliliter (mL) of water within 30 minutes (min) of a meal. On Day -1 and on Day 11 participants were also administered a single daily dose of 1.5 mL of solution for injection of midazolam concentrated 50 microgram (ug)/mL (total dosage=75 ug) orally with 240 mL of water within 30 minutes after a standard breakfast.
Nervous system disorders Headache	22.7% 5/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	5.6% 2/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	55.6% 5/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	40.0% 2/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	66.7% 6/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	22.2% 2/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	22.2% 2/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	55.6% 5/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	22.2% 2/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Head discomfort	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Dizziness	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Migraine	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Restless legs syndrome	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Somnolence	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Syncope	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Nervous system disorders Tension headache	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Nausea	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	2.8% 1/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	33.3% 3/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Diarrhoea	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	22.2% 2/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Vomiting	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	2.8% 1/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	22.2% 2/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Dry mouth	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Flatulence	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Injury, poisoning and procedural complications Limb injury	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Investigations Blood creatine phosphokinase increased	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Investigations Blood pressure increased	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Investigations Electrocardiogram PR shortened	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Investigations Electrocardiogram QT prolonged	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Skin and subcutaneous tissue disorders Solar urticaria	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
General disorders Fatigue	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Psychiatric disorders Bradyphrenia	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Psychiatric disorders Laziness	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Psychiatric disorders Hyperarousal	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Psychiatric disorders Tension	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	20.0% 1/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Ear and labyrinth disorders Vertigo	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Ear and labyrinth disorders Ear discomfort	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	16.7% 1/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 1/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Eye disorders Photophobia	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Immune system disorders Food allergy	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Infections and infestations Urinary tract infection	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Metabolism and nutrition disorders Dehydration	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Renal and urinary disorders Pollakiuria	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/22 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/36 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/5 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/6 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	11.1% 1/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.	0.00% 0/9 • Midazolam alone: From administration of midazolam on Day -1 until first administration of BI 1323495 on Day 1, up to 24 hours. All others: From first administration until 7 days after the last administration of BI 1323495, up to 18 days. Treated Set (TS): The treated set included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. Midazolam alone arm consisted of all subjects of the arms "70 mg BI 1323495 bid+Midazolam EM", "120 mg BI 1323495 bid+Midazolam EM", "150 mg BI 1323495 bid+ Midazolam EM" and 9 subjects of the arm "Placebo/Placebo+Midazolam" which were treated with midazolam on Day -1 of the trial.

Additional Information

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