Table of Contents 
Section Page 
1.0 Background and Rationale 3 
2.0 Objectives 8 
3.0 Study Design. 9 
4.0 Patient Eligibility 10 
5.0 Study Drug 11 
6.0 Study Drug Administration and Toxicides 12 
7.0 Safety and Efficacy 13 
8.0 Adverse Events and Removal from Study 14 
9.0 Efficacy Criteria..:... 14 
10.0 Informed Consent and IRB Approval 17 
11.0 Statistical Considerations 17 
12.0 References 17 
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Recombinant DNA Research, Volume 19 
