Table 1.

Schedule of assessment

Assessment	Screening, baseline		Treatment period				FU
Study day	−10 to −1	−4	1		8	15	24–72 h	1 week
			pre-dose	post-dose			post-dose	post-dose
Informed consent	x
Inclusion + exclusion criteria	x
Medical history	x
Virus serology (Hep, HIV)	x
Body height	x
Physical examination	x							x
Body weight	x							x
Karnofsky performance	x							x
ECG	x		x	•	•	•		x
Vital signs	x		x	•	•	•		x
Safety laboratory	x		x	•	•	•		x
Coagulation (PT, PIT)	x		x	•	•	•		x
Biological marker D-dimer	x	(x)	x		x	x		xx
Biopsy	x
Resection							x
Pharmacokinetics				x	x	x
Adverse events

•: To be taken or measured, respectively, at the assumed maximal concentration of the study drug in plasma 4 h post intake of dose.

x: To be taken, measured or performed.

(x): An effort was to be made to collect an additional sample during screening.

xx: 1–2 days after surgery and at follow-up.

ECG = Electrocardiogram, FU = follow-up visit, Hep = hepatitis, HIV = human immunodeficiency virus, PT = prothrombin time, PTT = partial thromboplastin time.