SM-03 Approval

Substantial Modification-3 (SM-3) got approved by the ethical committee in the Netherlands and in Belgium.

Implications SM-2:

  • Protocol v1.5:
    • Textual update on the line listing of SAE’s
    • Clarification exclusion criterion nr. 5.
  • Addition of the Haga Hospital
  • PI change for St. Antonius Hospital
  • PI change for VieCuri Hospital

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