Data acquisition and follow-up
ADVERSE EVENTS, ADVERSE EVENT
Patient data including imaging (i.e., MRI), liver specific and inflammatory laboratory parameters as well as quality of life (according to the EQ-5D questionnaire) were collected at baseline as well as 6 weeks, 3 and 6 months after iBT.Patients interrupting the study medication for 7 or more days were excluded from the primary analysis. Furthermore, occurrence of adverse events ≥ °II according to the Common Terminology Criteria for Adverse Events (CTCAE 4.02) led to a discontinuation of the study drugs for safety purposes.Processing of the imaging data was performed as in the prequel study (Seidensticker et al. All measurements within this process were blinded for the study group.