STUDY PROCEDURES | VISIT 1 | VISIT 2 |
---|---|---|
Informed consent | X | Â |
Inclusion/exclusion criteria | X | Â |
Medical/surgical history | X | X |
Vital signs | X | X |
Physical examination | X | X |
Concomitant medication | X | X |
Alcohol consumption questionnaire (AUDIT) | X | X |
Quality of life questionnaires (EuroQoL 5d-3) | X | Â |
Health survey (SF-12) | X | Â |
LABORATORY ASSESSMENTS | ||
 HCV/HBV serologies | X |  |
 ALT/AST levels | X | X |
 GGT/AP levels | X | X |
 Haematology | X |  |
 Biochemistry | X |  |
 Coagulation | X |  |
 Leucocyte and CRP | X |  |
 Antibodies for autoimmune and celiac diseases |  | X |
 Biochemistry: TSH, ceruloplasmin, α1AT, bilirubin |  | X |
BIOBANK | ||
 Blood samples: plasma, serum, DNA. | X |  |
VC TRANSIENT ELASTOGRAPHY | X | X |
ABDOMINAL ULTRASOUND | Â | X |
LIVER BIOPSY | Â | X |
AE assessment | X | X |