Substantial Amendment 6.0, 07/09/2015

Substantial Amendment 6.0

  • 11-YH-0290 Favourable Amendment 6 - 21-Sep-2015 [.pdf]
  • Amendment 6 Cover Letter to REC [.pdf]
  • Amendment Form MHRA Eurdact - Ready for Submission[.pdf]
  • MHRA Approval Amendment 6 [.pdf]
  • Release of Medical Information Form V1.0 27-Aug-2015[.pdf]
  • SA6 Annexe 2 Form Section F - Description of Each Substaintial Amendment [.pdf]
  • ICF v5.0 25-Aug-2015 Final [.pdf]
  • ICF v5.0 25-Aug-2015 Tracked Changes [.pdf]
  • PIS v6.0 25-Aug-2015 Final [.pdf]
  • PIS v6.0 25-Aug-2015 Tracked Changes [.pdf]
  • Protocol Version 4.0 25-Aug-2015 Final [.pdf]
  • Protocol Version 4.0 25-Aug-2015 Tracked Changes [.pdf]
  • PIS Addendum Version 1.0 25-Aug-2015 [.pdf]