Page 
V. Human Protocol 56 
VI. Production of CFTR Adenovirus 65 
VII. Overall Risk/Benefit 73 
VIII. References 78 
IX. Informed Consent 86 
X. Points to Consider 92 
Description of Protocol (I) 92 
Special Issues (II) 107 
Other Federal Agencies (III) 107 
XI. Requested Documentation 108 
A. IBC Communication 108 
B. IRB Communication 114 
C. One Page Scientific and Non-Technical Abstracts 118 
D. Curricula Vitae of Key Personnel 120 
XII. Appendix 
A. Engelhardt et al. Nature Genet. 2:240-247. 
B. Johnson et al. Nature Genet. 2:21-25. 
C. Engelhardt et al. Proc. Natl. Acad. Sci. U. S. A. 88:11192-11196. 
D. Engelhardt et al. J. Clin. Invest. (In Press) 
E. Engelhardt et al. Nature Genet. (In Press) 
F. Construction of adenoviral vector 
G. Safety data - Adenoviral vectors in mice (D. Meuten, D.V.M., Ph.D.) 
H. Safety data- adenoviral vectors in Rhesus monkeys 
I. Safety data - Ad5-CMV-lacZ in Baboon (B208) 
J. Whitsett et al. Nature Genet. 2:13-20. 
K. Safety data, including shedding - adenoviral vectors in Baboon (B210) 
L. Adenoviral Core Facility - University of Michigan 
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