| Timeline | Data Review by | Type of Data |
|---|---|---|
| Before study initiation | Entire DMC | Study protocol, safety concerns, DMC Charter and associated procedures/reports |
| After 6 and 12 months of recruitment and yearly thereafter | Entire DMC | Enrolment summary Tables of grade 3 and 4 AEs and SAEs, SARs and SUSARs. Any other requested data |
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