Attachment II - Page 6 
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(2) How will patients be monitored to assure their safety? What 
diagnostic tests will be performed following administration 
of the vector and inserted DNA? For what purposes and at 
what intervals? 
(3) What are the primary clinical endpoints of the study? 
(4) Will there be long-term patient follow-up? If a patient 
should die, will an autopsy be requested? 
(5) What precautions will be taken, if any, to protect other 
patients (e.g . , those sharing a roan) and health-care 
workers or family members from risk, for example, from the 
low probability of retroviral infection? 
d. Statistical Considerations 
(1) How many patients will be involved in the study? Over what 
period of time? Will there be control subjects in the 
study? If so, how many? 
(2) What effects would be detectable with this number of patients 
(and controls)? 
(3) Qualifications of investigators, adequacy of laboratory, and 
clinical facilities 
(a) What professional personnel (medical and non-medical) 
will be involved in the proposed study? What are 
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