5.4.1 Inclusion criteria 
5.4.2 Exclusion criteria 
5.5 Safety and efficacy parameters 
5.5.1 Definitions 
5.5.2 Safety 
5. 5. 2.1 General clinical safety parameters 
5. 5. 2. 2 Vector-related safety parameters 
5.5.3 Efficacy Parameters 
5. 5. 3.1 Biologic efficacy parameters 
5. 5. 3. 2 Clinical efficacy parameters 
5.6 Clinical protocol 
5.6.1 Overview 
5.6.2 Baseline period 
5.6.3 Vehicle control period 
5.6.4 AdCFTR experimental treatment period 
5.6.5 Management of intercurrent illness 
5.6.6 Management of adverse events 
5.6.7 Ability of the protocol to answer the questions posed in the 
introduction to the general design (Section 5.1) 
5.8 Additional safety issues 
5.8.1 Health care workers 
5.8.2 Environment 
5.9 Risk-benefit considerations for the patient 
5.10 Post-study patient follow-up 
5.11 Clinical facilities for the study 
5.12 Privacy and confidentiality 
5.13 Informed consent 
5.14 Reporting of serious adverse affects 
5.15 Future directions 
6. Protocol in the NIH Recombinant DNA Advisory Committee "Points to Consider" 
format 
7. References 
Appendix 1 - 
Appendix 2 - 
Appendix 3 - 
Appendix 4 - 
Copy of Rosenfeld, M.A. et al . 
Copy of Mastrangeli, A. et al. 
Sequence data 
Approval documents 
Cell 1992; 68: 143-155 
J. Clin Invest 1992 (in press) 
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