Time point | Study period | |||||
---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | |||
− t1 | 0 | 0 weeks | 6 weeks | 12 weeks | 24 weeks | |
Enrollment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Screening | X | |||||
Allocation | X | |||||
Interventions | ||||||
[ICR] | X | X | X | |||
[SOC] | X | X | X | |||
Examinations | ||||||
MRI-PDFF, MRE | X | X | ||||
Anthropometrics | X | X | X | X | ||
Blood sample | X | X | X | |||
Stool, urine sample | X | X | X |