Screening | Allocation | Observation time | Closeout | |||||
---|---|---|---|---|---|---|---|---|
Time | t−1 | t0 | t1 | t2 | t3 | t4 | t5 | t6 |
Day | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Eligibility criteria | x | |||||||
Informed consent | x | |||||||
Randomisation | x | |||||||
Baseline data | x | |||||||
Muscle biopsy and ultrasound | x1 | x | ||||||
Start feeding | x2 | |||||||
Vital parameters | x | x | x | x | x | x | x | x |
Primary variables | x | x | x | x | x | x | x | |
Secondary variables3 | x | x | x | x | x | x | x | x |
SAEs | x | x | x | x | x | x | x |