Table 3 Study-specific actions ^a

Informed consent

X

Checking inclusion and exclusion criteria

X

Demographics

X

Medical history (with focus on liver disease)

X

NOD2 genetic testing

X

Concomitant diseases

X

X

X

Concomitant medications

X

X

X

MELD and Child-Pugh-scores

X

X

Clinical assessment and vital signs

X

X

12-lead ECG

X

X

Blood tests (safety parameters)

X

X

Recording of adverse events

X

X

Distribution and return of study medication

X

Collection of ascites samples (clinically indicated puncture)

X

X

Collection of stool samples

X