Trial Outcomes & Findings for EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer (NCT NCT01008475)

Last Updated: 2016-03-30

Results Overview

DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =\< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

232 participants

Primary outcome timeframe

Time from the first dose of study drug up to 2 weeks

Results posted on

2016-03-30

Participant Flow

This study consists of two parts, safety part and randomized part. A total of 16 subjects were included in the safety part and 216 subjects were included in the randomized part of the study. The subjects who participated in the safety part of the study were not included in the randomized part of the study.

Participant milestones

Participant milestones
Measure	Safety Part: EMD 525797 250 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: Standard of Care (SoC) Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 500 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 1000 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Overall Study STARTED	3	3	7	3	72	73	71
Overall Study Safety Analysis Set	3	3	7	3	73	72	69
Overall Study COMPLETED	3	3	7	3	67	67	67
Overall Study NOT COMPLETED	0	0	0	0	5	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Part: EMD 525797 250 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: Standard of Care (SoC) Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 500 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 1000 mg + SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Overall Study Ongoing treatment at data cut-off date	0	0	0	0	5	6	4

Baseline Characteristics

EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Part: EMD 525797 250 mg + Standard of Care (SoC) n=3 Participants Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=3 Participants Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 750 mg + SoC n=7 Participants Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg + SoC n=3 Participants Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: SoC n=72 Participants Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Randomized Part: EMD 525797 1000 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Total n=232 Participants Total of all reporting groups
Age, Continuous	62.3 Years STANDARD_DEVIATION 11.5 • n=5 Participants	57.7 Years STANDARD_DEVIATION 11.2 • n=7 Participants	60.4 Years STANDARD_DEVIATION 6.2 • n=5 Participants	63.0 Years STANDARD_DEVIATION 7.2 • n=4 Participants	56.2 Years STANDARD_DEVIATION 12.11 • n=21 Participants	58.9 Years STANDARD_DEVIATION 12.18 • n=8 Participants	59.9 Years STANDARD_DEVIATION 10.63 • n=8 Participants	58.5 Years STANDARD_DEVIATION 11.49 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	27 Participants n=21 Participants	36 Participants n=8 Participants	23 Participants n=8 Participants	95 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	45 Participants n=21 Participants	37 Participants n=8 Participants	48 Participants n=8 Participants	137 Participants n=24 Participants

PRIMARY outcome

Timeframe: Time from the first dose of study drug up to 2 weeks

Population: Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=3 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=3 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=7 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC n=3 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)	0 subjects	0 subjects	0 subjects	0 subjects

PRIMARY outcome

Timeframe: Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)

Population: Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.

PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=72 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Randomized Part: Progression Free Survival (PFS)	5.6 months Interval 4.2 to 6.9	5.4 months Interval 4.1 to 6.0	5.6 months Interval 4.1 to 6.9	—

SECONDARY outcome

Timeframe: Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)

Population: ITT analysis set included all the subjects who were randomized into the trial.

OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=72 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Overall Survival (OS) Time	11.6 months Interval 9.8 to 15.7	15.0 months Interval 10.9 to 19.2	14.4 months Interval 9.8 to 19.3	—

SECONDARY outcome

Timeframe: Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)

Population: ITT analysis set included all the subjects who were randomized into the trial.

TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=72 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Time to Progression (TTP)	5.8 months Interval 4.4 to 7.2	5.6 months Interval 4.2 to 8.3	6.5 months Interval 4.2 to 7.1	—

SECONDARY outcome

Timeframe: Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)

Population: ITT analysis set included all the subjects who were randomized into the trial.

Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=72 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Number of Subjects With Tumor Response CR	2 Subjects	1 Subjects	0 Subjects	—
Number of Subjects With Tumor Response PR	17 Subjects	19 Subjects	18 Subjects	—

SECONDARY outcome

Timeframe: Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)

Population: ITT analysis set included all the subjects who were randomized into the trial.

TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.

Outcome measures

Outcome measures
Measure	Safety Part: EMD 525797 250 mg + SoC n=72 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=73 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=71 Participants Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Time to Treatment Failure (TTF)	5.2 months Interval 4.4 to 6.2	4.3 months Interval 3.6 to 6.1	4.8 months Interval 3.3 to 6.6	—

Adverse Events

Safety Part: EMD 525797 250 mg + SoC

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Safety Part: EMD 525797 500 mg + SoC

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Safety Part: EMD525797 750 mg + SoC

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Safety Part: EMD 525797 1000 mg +SoC

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard of Care (SoC)

Serious events: 30 serious events

Other events: 72 other events

Deaths: 0 deaths

EMD 525797 500 mg + SoC

Serious events: 27 serious events

Other events: 72 other events

Deaths: 0 deaths

EMD 525797 1000 mg + SoC

Serious events: 34 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Part: EMD 525797 250 mg + SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=7 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Standard of Care (SoC) n=73 participants at risk Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	EMD 525797 500 mg + SoC n=72 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	EMD 525797 1000 mg + SoC n=69 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Atrial Fibrillation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Cardiac Failure Acute	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Tachyarrhythmia	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Tachycardia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Polyneuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Syncope	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Ascites	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Colitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Colonic Obstruction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Constipation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	10.1% 7/69 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Enteritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Enterovesical Fistula	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Stenosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Toxicity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Ulcer Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Nausea	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Periodontitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Subileus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Asthenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Death	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Device Malfunction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Disease Progression	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Fatigue	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders General Physical Health Deterioration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Mucosal Inflammation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Multi-Organ Failure	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Performance Status Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Pyrexia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hepatic Failure	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Jaundice Cholestatic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Immune system disorders Anaphylactic Shock	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Immune system disorders Hypersensitivity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Abdominal Sepsis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Abdominal Wall Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Cellulitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Device Related Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Device Related Sepsis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Erysipelas	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Febrile Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Gastroenteritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Gastrointestinal Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Peritonitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Pneumonia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Rectal Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Sepsis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Septic Shock	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Urinary Tract Infection	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Bilirubin Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Creatinine Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Coagulation Factor Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations General Physical Condition Abnormal	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Neutrophil Count Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Cerebrovascular Accident	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Coma	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Dizziness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Epilepsy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Headache	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Renal Failure	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Renal Failure Acute	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.8% 5/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Surgical and medical procedures Thrombosis Prophylaxis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Deep Vein Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Venous Thrombosis Limb	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.

Other adverse events

Other adverse events
Measure	Safety Part: EMD 525797 250 mg + SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 500 mg + SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD525797 750 mg + SoC n=7 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Safety Part: EMD 525797 1000 mg +SoC n=3 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	Standard of Care (SoC) n=73 participants at risk Cetuximab was administered at a dose of 400 milligram per square meter (mg/m\^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	EMD 525797 500 mg + SoC n=72 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.	EMD 525797 1000 mg + SoC n=69 participants at risk Cetuximab was administered at a dose of 400 mg/m\^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m\^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m\^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Eye Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Eyelid Oedema	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Chills	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 28 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	20.8% 15/72 • Number of events 40 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	26.1% 18/69 • Number of events 33 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Anaemia Of Malignant Disease	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Aplastic Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Faecal Vomiting	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Eyelid Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Extravasation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Hypochromic Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Eyelids Pruritus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	10.1% 7/69 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Leukocytosis	33.3% 1/3 • Number of events 9 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Leukopenia	66.7% 2/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.9% 3/7 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	19.2% 14/73 • Number of events 63 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	19.4% 14/72 • Number of events 55 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	23.2% 16/69 • Number of events 70 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Microcytic Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	32.9% 24/73 • Number of events 96 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	36.1% 26/72 • Number of events 91 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	37.7% 26/69 • Number of events 85 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Iritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Normochromic Normocytic Anaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Splenic Vein Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.6% 7/73 • Number of events 17 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Angina Pectoris	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Atrial Tachycardia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Left Ventricular Dysfunction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Meibomianitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Myocardial Ischaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Right Ventricular Dysfunction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Sinus Tachycardia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Tachycardia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Congenital, familial and genetic disorders Congenital Hair Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Congenital, familial and genetic disorders Trichomegaly	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Miosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Ear and labyrinth disorders External Ear Inflammation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Ear and labyrinth disorders Vertigo	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Blepharitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Conjunctivitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 21 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.6% 8/69 • Number of events 14 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Dry Eye	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.8% 5/73 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.9% 5/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.7% 6/69 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Tenderness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Erythema Of Eyelid	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Fatigue	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	20.5% 15/73 • Number of events 21 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	22.2% 16/72 • Number of events 26 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	24.6% 17/69 • Number of events 33 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Intestinal Fistula	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Ocular Hyperaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Ocular Icterus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Vision Blurred	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Visual Acuity Reduced	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Eye disorders Visual Impairment	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Distension	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	15.1% 11/73 • Number of events 18 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	19.4% 14/72 • Number of events 24 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	26.1% 18/69 • Number of events 24 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Anal Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Anorectal Discomfort	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Aphthous Stomatitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	13.0% 9/69 • Number of events 16 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Ascites	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Colitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Constipation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.6% 7/73 • Number of events 14 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.7% 7/72 • Number of events 13 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	21.7% 15/69 • Number of events 22 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	57.1% 4/7 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 15 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.5% 31/73 • Number of events 128 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 48/72 • Number of events 197 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	65.2% 45/69 • Number of events 209 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.9% 5/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Enteritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Enterovesical Fistula	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Food Poisoning	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastritis Erosive	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Motility Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrointestinal Toxicity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gastrooesophageal Sphincter Insufficiency	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Gingival Bleeding	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Intestinal Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Intestinal Villi Atrophy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Lip Ulceration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Mesenteric Vein Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Mucous Stools	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.8% 21/73 • Number of events 41 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	34.7% 25/72 • Number of events 62 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	36.2% 25/69 • Number of events 59 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Oral Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Periodontal Disease	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Rectal Discharge	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Rectal Tenesmus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.0% 8/73 • Number of events 9 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	25.0% 18/72 • Number of events 37 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	30.4% 21/69 • Number of events 35 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Subileus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Tongue Ulceration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Tooth Discolouration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Tooth Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Toothache	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	19.2% 14/73 • Number of events 21 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	16.7% 12/72 • Number of events 24 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	24.6% 17/69 • Number of events 30 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Asthenia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.9% 3/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 15 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	20.8% 15/72 • Number of events 26 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	29.0% 20/69 • Number of events 66 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Catheter Site Erythema	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Catheter Site Rash	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Chest Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Feeling Cold	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders General Physical Health Deterioration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Impaired Healing	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Influenza Like Illness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Injection Site Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Localised Oedema	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Malaise	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Mucosal Inflammation	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.9% 3/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Non-Cardiac Chest Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Oedema Peripheral	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Performance Status Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Pyrexia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	18.1% 13/72 • Number of events 23 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.6% 8/69 • Number of events 19 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Secretion Discharge	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
General disorders Xerosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Biliary Colic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Cholestasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hepatic Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hepatic Vein Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hepatomegaly	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 16 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Hepatobiliary disorders Jaundice	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Immune system disorders Contrast Media Allergy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Immune system disorders Drug Hypersensitivity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Immune system disorders Hypersensitivity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Abdominal Wall Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Anal Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Bronchitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Catheter Site Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Cellulitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Cystitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Device Related Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Eye Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Folliculitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Fungal Skin Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Furuncle	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Gastroenteritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Gastroenteritis Viral	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Gastrointestinal Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Genital Candidiasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Herpes Zoster	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Hordeolum	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Infected Fistula	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Infected Skin Ulcer	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Influenza	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Keratitis Herpetic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Laryngitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Localised Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Lung Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Lyme Disease	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Nail Bed Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.8% 5/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Oesophageal Candidiasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Oral Candidiasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Oral Fungal Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Oral Herpes	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Oral Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Otitis Externa	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Paronychia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	15.1% 11/73 • Number of events 25 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.3% 6/72 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 9 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Pharyngitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Pharyngotonsillitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Pneumonia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Postoperative Wound Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Pulpitis Dental	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Rash Pustular	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Rhinitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.3% 6/72 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Sepsis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Severe Acute Respiratory Syndrome	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Streptococcal Urinary Tract Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Subcutaneous Abscess	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Tinea Pedis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Tonsillitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.2% 6/73 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Urinary Tract Infection	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.3% 6/72 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.7% 6/69 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Viral Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Contrast Media Reaction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Head Injury	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Incisional Hernia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Post Procedural Discharge	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Suture Related Complication	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Activated Partial Thromboplastin Time	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Activated Partial Thromboplastin Time Prolonged	33.3% 1/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Alanine Aminotransferase Increased	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	16.4% 12/73 • Number of events 22 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Aspartate Aminotransferase Increased	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.0% 8/73 • Number of events 9 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.7% 6/69 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Bilirubin Increased	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Glucose Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 12 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Iron Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Magnesium Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Pressure Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Thyroid Stimulating Hormone Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Body Temperature Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations C-Reactive Protein Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Creatinine Renal Clearance Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Ejection Fraction Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Electrocardiogram T Wave Inversion	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Eosinophil Count Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Gamma-Glutamyltransferase Increased	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Haematocrit Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Haemoglobin Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations International Normalised Ratio Increased	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Neutrophil Count Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Neutrophil Count Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Platelet Count Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Red Blood Cell Count Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Thrombin Time Prolonged	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Transaminases Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Urine Output Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Weight Decreased	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.7% 7/72 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.5% 10/69 • Number of events 12 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations Weight Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Investigations White Blood Cell Count Increased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.8% 5/73 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	13.0% 9/69 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Decreased Appetite	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.9% 3/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 11 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	15.3% 11/72 • Number of events 15 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	29.0% 20/69 • Number of events 36 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.8% 5/73 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	15.3% 11/72 • Number of events 29 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.6% 8/69 • Number of events 12 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.5% 4/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	18.1% 13/72 • Number of events 27 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	21.7% 15/69 • Number of events 27 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	23.3% 17/73 • Number of events 38 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	31.9% 23/72 • Number of events 57 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	20.3% 14/69 • Number of events 40 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	13.0% 9/69 • Number of events 19 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Iron Deficiency	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Plasma Protein Metabolism Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Inguinal Mass	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Haematuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Muscle Twitching	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Osteopenia	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Osteoporosis	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Soft Tissue Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Cholinergic Syndrome	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Diabetic Neuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Dizziness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Dizziness Postural	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Dysgeusia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	11.6% 8/69 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Encephalopathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Epilepsy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Hepatic Encephalopathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Hypogeusia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Lethargy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Neuropathy Peripheral	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Neurotoxicity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Paraesthesia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Polyneuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Radiculitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Leukocyturia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Sciatica	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Speech Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Toxic Neuropathy	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Tremor	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Nervous system disorders Visual Field Defect	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Agitation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Anxiety	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Confusional State	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Decreased Interest	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Depressed Mood	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Depression	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Depressive Symptom	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Emotional Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Psychiatric disorders Insomnia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Anuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Dysuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Glycosuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Oliguria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Polyuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Renal Colic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Renal Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Urethral Obstruction	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Renal and urinary disorders Urinary Retention	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Balanitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Breast Mass	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Breast Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Haematospermia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Reproductive system and breast disorders Vulvovaginal Pruritus	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Asthmatic Crisis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Bronchial Secretion Retention	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.6% 7/73 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.3% 6/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.6% 4/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.6% 7/73 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.9% 5/72 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	10.1% 7/69 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Obstructive Airways Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Sputum Discoloured	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	28.6% 2/7 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	16.4% 12/73 • Number of events 26 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.7% 7/72 • Number of events 18 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	17.4% 12/69 • Number of events 33 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	66.7% 2/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	26.0% 19/73 • Number of events 26 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	16.7% 12/72 • Number of events 19 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	21.7% 15/69 • Number of events 26 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dermal Cyst	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	33.3% 1/3 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	42.9% 3/7 • Number of events 7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	17.8% 13/73 • Number of events 19 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	19.4% 14/72 • Number of events 41 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	26.1% 18/69 • Number of events 42 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	5.8% 4/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Dry Skin	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 14 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.5% 9/72 • Number of events 19 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	15.9% 11/69 • Number of events 16 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.9% 5/72 • Number of events 14 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Exfoliative Rash	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Nail Disorder	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Nail Toxicity	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.6% 7/73 • Number of events 10 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	9.7% 7/72 • Number of events 12 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	10.1% 7/69 • Number of events 16 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Penile Ulceration	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Pigmentation Disorder	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	8.2% 6/73 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.5% 9/72 • Number of events 13 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.5% 10/69 • Number of events 15 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Pruritus Generalised	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	100.0% 3/3 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	100.0% 3/3 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	50.7% 37/73 • Number of events 75 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	51.4% 37/72 • Number of events 103 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	40.6% 28/69 • Number of events 76 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Generalised	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Papular	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.2% 3/72 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Rash Vesicular	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Chapped	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Erosion	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Fissures	33.3% 1/3 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	12.3% 9/73 • Number of events 12 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	6.9% 5/72 • Number of events 14 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 8 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Subcutaneous Nodule	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 4 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 5 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Aortic Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Circulatory Collapse	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Deep Vein Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.9% 2/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Flushing	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Haematoma	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Hypertension	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	14.3% 1/7 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.1% 3/73 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	4.3% 3/69 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Hypotension	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.7% 2/73 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	2.8% 2/72 • Number of events 3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	7.2% 5/69 • Number of events 6 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Orthostatic Hypotension	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Pallor	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/69 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Peripheral Ischaemia	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Phlebitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Thrombophlebitis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 2 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/72 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Venous Insufficiency	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	33.3% 1/3 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/73 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
Vascular disorders Venous Thrombosis	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/7 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/3 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	1.4% 1/73 • Number of events 1 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/72 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.	0.00% 0/69 • From the first dose of study drug administration up to 50 days after the last dose of study drug administration The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.

Additional Information

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Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

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Principal investigator is a sponsor employee
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