TABLE OF CONTENTS 
Page 
1.0 OBJECTIVES 
2.0 BACKGROUND 
3.0 RATIONAL FOR CURRENT PROPOSAL 
4.0 STUDY OUTLINE AND SAFETY 
5.0 PLAN OF CLINICAL STUDY 
6.0 EVALUATION OF EFFECTS 
7.0 IMPACT OF OUTCOME ON SUBSEQUENT TREATMENT . . 
8.0 STUDY SIZE AND STATISTICAL CONSIDERATIONS 
9.0 DRUG INFORMATION 
10.0 PATIENT ELIGIBILITY 
11.0 OUTLINE OF THERAPY 
12.0 CONCURRENT TREATMENT AND SUPPORTIVE CARE . . 
13.0 EVALUATION DURING THERAPY 
14.0 RESPONSE CRITERIA 
15.0 OFF-STUDY CRITERIA 
16.0 RECORDS TO BE KEPT 
17.0 INFORMED CONSENT 
18.0 SUMMARY STATEMENT 
STATEMENT OF UNDERSTANDING 
ASSENT FORM 
APPENDICES 
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Recombinant DNA Research, Volume 17 
