225 9.7. Investigator’s Final Report ................................................................................... 226 9.8. Records Retention ................................................................................................. 226 9.9. Publications .......................................................................................................... 227 10. Study Management and Monitoring ............................................................... 228 10.1. External Data Monitoring Committee ......................................................... 228 10.2. Monitoring of the Study .............................................................................. 228 10.2.1. Inspection of Records ............................................................................... 229 10.3. Management of Protocol Amendments and Deviations ....................................... 229 10.3.1. Modification of the Protocol ..................................................................... 229 10.3.2. Protocol Deviations .................................................................................. 230 10.4 Study Termination .................................................................................................. 230 10.5. First Interpretable Results (FIR) Report ............................................................... 231 10.6. Final Complete Clinical Study Report (CSR) ....................................................... 231 11. Reference List .................................................................................................................. 232 12. Appendices ...................................................................................................................... 258 12.1 Appendix 1. Azacitidine (Vidaza®) US Prescribing Information .......................... 258 12.2. Appendix 2. Decitabine (Dacogen®) US Prescribing Information ....................... 258 12.3.