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. 2021 Nov 11;22:792. doi: 10.1186/s13063-021-05719-2
Screening Baseline6, 9, 11 Day 74 Day 144 Day 214 Day 282, 11 Day 42 1,4 Discharge10 Day 903 Unscheduled
Informed consent X
Demographic data X
Inclusion/exclusion criteria X X
HIV test^ X
Pregnancy test+ X5 X
Hepatitis B and C serology^ X
Genetic sequencing (PNPLA3) X
Urinary ethyl glucuronide X X X X X
Alcohol consumption X X X X
Duration since admission to hospital X X
Medical history X
Prior/concomitant medications X X X X X X X X X
Vital signs X X X X X X X X X X
Physical exam X X X X X X X X X
Weight X X1 X X
Height X
Calorie and protein intake X X X X X X X X
Randomisation X
IMP/placebo administration X X
Prothrombin time X X X X X X X X X
Haematology% X X X X X X X X X X
Clinical chemistry% X X X X X X X X X X
Serum CK18-M30/M65 sample X X X X X X X X
DF, MELD, GAHS scores X X X X X X X X X
Lille score X
Overt GI haemorrhage assessment$ X X X X X X X X X
Acute kidney injury assessment$ X X X X X X X X X
EDTA sample for DNA (16S) X X X X X X X
PBMC sample~ X X X X X
Infection/sepsis/SIRS screen X X X X X X X X X X
USS Liver assessment$ X
Fibroscan measurement$ X X X
Gene expression sample X X
Liver biopsy (incl. HVPG measurement*)8 X X
Adverse events X X X X X X X X
PK/PD samples in blood and ascites fluid # X X X X X X X X
Biomarker serum X X X X X X X X
Stool and saliva sample X X X X