End of year 1
|
-> Intermediate assessment of recruitment level:
|
|
- If fraction of randomized patients <5% of total count: ongoing recruitment, else abortion of randomization
|
End of year 2
|
-> Second intermediate assessment of recruitment level:
|
|
- If fraction of randomized patients <10% of total count: ongoing recruitment, else abortion of randomization
|
End of year 4
|
-> End of recruitment phase
|
|
-
|
Year 5+6
|
-> Follow-up
|
Year 7+8
| |
Year 9
| |
End of year 9
|
-> End of Follow-Up
|
|
-> Final analysis of the primary clinical endpoint: Evaluation of the overall-survival
|