Start | -> Start of recruitment phase (presumably Sep. 2009) |
---|---|
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 | Â |
Year 9 | Â |
End of year 9 | -> End of Follow-Up |
 | -> Final analysis of the primary clinical endpoint: Evaluation of the overall-survival |