Non Substantial Amendment 02

  • NSA02 REC Cover Letter 22nd May 2015 [pdf]
  • NSA02 Summary of Document Changes for Sites version 1.0 dated 20-May-2015 [pdf]
  • NSA02 REC Acknowledgment Minor Amendment Letter 27th May 2015 [pdf]
  • Trial Protocol, version 2.0b dated 07-May-2015 [pdf]
  • Arm A GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm B GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm C GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm D GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm E GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm NA Cohort NA1 GP Letter, version 3.0a dated 21-May-2015 [pdf]
  • Arm A Patient Diary version 1.0a dated 18-May-2015 [pdf]
  • Arm B Patient Diary version 1.0a dated 18-May-2015 [pdf]
  • Arm C Patient Diary version 1.0a dated 18-May-2015 [pdf]
  • Arm D Patient Diary version 1.0a dated 18-May-2015 [pdf]
  • Arm E Patient Diary version 1.0a dated 18-May-2015 [pdf]
  • Arm A PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Arm B PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Arm C PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Arm D PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Arm E PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Arm NA Cohort NA1 PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Molecular Testing Biopsy PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Pre-Trial Biopsy PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Post-Trial Biopsy PIS and ICF version 2.0a dated 08-May-2015 [pdf]
  • Pharmacy Manual version 2.0 dated 20-May-2015 [pdf]
  • Laboratory Manual version 2.0 dated 20-May-2015 [pdf]
  • CRF Completion Guidelines version 2.0 dated 20-May-2015 [pdf]
  • Adverse Event Form version 2.0 dated 19-May-2015 [pdf]
  • Arm NA Cohort NA1 Vital Signs Form version 2.0 dated 19-May-2015 [pdf]
  • Serious Adverse Events Form version 2.0 dated 19-May-2015 [pdf]
  • SAE Fax Cover Sheet version 2.0 dated 19-May-2015 [pdf]
  • Smoking Questionnaire v1.0a dated 18-May-2015 [pdf]
  • CRF Version Checklist version 3.0 dated 21-May-2015 [pdf]