- Clinical Review Report
- ABBREVIATIONS
- EXECUTIVE SUMMARY
- 1. INTRODUCTION
- 2. OBJECTIVES AND METHODS
- 3. RESULTS
- 4. DISCUSSION
- 5. CONCLUSIONS
- APPENDIX 1 PATIENT INPUT SUMMARY
- APPENDIX 2 LITERATURE SEARCH STRATEGY
- APPENDIX 3 EXCLUDED STUDIES
- APPENDIX 4 DETAILED OUTCOME DATA
- APPENDIX 5 VALIDITY OF OUTCOME MEASURES
- APPENDIX 6 SUMMARY OF OPEN-LABEL EXTENSION PHASE OF STUDY 079 AND STUDY 080
- REFERENCES
- Pharmacoeconomic Review Report
- ABBREVIATIONS
- EXECUTIVE SUMMARY OF THE PHARMACOECONOMIC SUBMISSION
- 1. INTRODUCTION
- 2. METHODS
- 3. RESULTS
- 4. DISCUSSION
- 5. CONCLUSIONS
- APPENDIX 1 COST COMPARISON TABLE
- APPENDIX 2 SUMMARY OF KEY OUTCOMES
- APPENDIX 3 ADDITIONAL INFORMATION
- APPENDIX 4 SUMMARY OF CLINICAL INFORMATION
- APPENDIX 5 OTHER HEALTH TECHNOLOGY ASSESSMENT FINDINGS
- REFERENCES
- CDEC Final Recommendation