Visit 0 | Screening | Screening for eligibility, exclusion and inclusion criteria. Informed consent if not already given. |
Visit 1 | Day 1: enrolment | Enrolment, transjugular liver biopsy, haemodynamic investigations, DEXA scan. |
Visit 1 | Day 1: randomisation | Randomisation, sampling for biobank, biochemistry, Short Physical Performance Battery, life space assessment, medication. |
Visit 2 | Day 20–35 (1 month) | Dose adjustment, safety, biochemistry for safety including creatine kinase. |
Visit 3 | Day 85–100 (3 months) | Dose adjustment, safety, biochemistry and sampling for biobank. |
Visit 4 | Day 175–190 (6 months) | Dose adjustment, safety, biochemistry, sampling for biobank, transjugular liver biopsy, haemodynamic investigations, DEXA scan, Short Physical Performance Battery, life space assessment. |
Visit 5 | Day 265–280 (9 months) | Dose adjustment, safety, biochemistry. |
Visit 6 | Day 355–370 (12 months) | Dose adjustment, safety, biochemistry and sampling for biobank. |
Visit 7 | Day 450–465 (15 months) | Dose adjustment, safety, biochemistry. |
Visit 8 | Day 535–550 (18 months) | Dose adjustment, safety, biochemistry, sampling for biobank, end of study medication, Short Physical Performance Battery, life space assessment. |
Follow-up | Day 540–1825 | Data registration on mortality and hospitalisations from clinical registries. |