TABLE OF CONTENTS 
Section Title Pmge 
1.0 
Schematic Representation 
1 
2.0 
Summary of Events 
2 
3.0 
Infoduction 
3 
3.1 
Overall Status of Treatment 
3 
3.2 
Process in Invest, of Vaccines 
4 
3.3 
Gene Transfer Clinical Studes 
6 
3.4 
Preclinical Studes 
8 
4.0 
Objectives of the Study 
22 
4.1 
Objective 1 
22 
4.2 
Objective II 
22 
4.3 
Objective III 
22 
4.4 
Objective IV 
23 
5.0 
Patient Selection 
23 
6.0 
Study Design 
24 
7.0 
Patient Registration 
24 
6.0 
Treatment Plan 
24 
9.0 
Measurement of Effects 
26 
10.0 
Administrative Aspects 
28 
11.0 
References 
29 
12.0 
12.1 
Appendices 
A 
31 
12.2 
B 
33 
12.3 
C 
35 
12.4 
D 
38 
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