Substantial Amendment 02


  • Substantial Amendment 2 Favourable Opinion Letter 12-Oct-15 [.pdf]
  • A19 Changes Form [.pdf]
  • MHRA Amendment Form [.pdf]
  • Patient Information Sheet A V1 [.pdf]
  • Patient Information Sheet B V1 [.pdf]
  • Protocol V2 [.pdf]
  • Summary Sheet V3 [.pdf]
  • MHRA Products Form Snapshot [.pdf]
  • MHRA Notice of Acceptance [.pdf]
  • Rec Form [.pdf]
  • Trial Synopsis V3 [.pdf]