Study period | ||||||
---|---|---|---|---|---|---|
Pre-intervention | Intervention (within 6 months of randomisation) | Post-intervention | ||||
≤ 10 days before randomisation | Within 3 days of randomisation | 7 days after intervention | Clinical success | After five years of clinical success | ||
Screening | Randomisation | Intervention | Assessment | Follow-up | ||
Informed consent | X | |||||
Eligibility screening | X | |||||
Assessment of WON | X | |||||
Assessment of symptoms | X | X | ||||
Body temperature | X | X | X | |||
Blood testa | X | X | X | |||
Imaging studyb | X | Xc | X | |||
Electrocardiogram | X | |||||
Randomisation | X | |||||
Interventions | X | |||||
Assessment of primary endpoint | X | |||||
Assessment of secondary endpoints | X | X | X | |||
Monitoring of adverse events | X | X | X |