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MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2 Minor Patient’s Assent to Participate In A Clinical Research Study 
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STUDY NUMBER: 
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CONTINUATION: page _LL of _21_ pages. 
on at least three separate occasions. The subjects will undergo the same 
tests that they have undergone in the previous two parts of the protocol (see 
Table 5 . 6 .4-A) . 
The natural history of cystic fibrosis is associated with exacerbations 
(worsenings) of the disease, particularly respiratory problems. It is thus 
possible that among the 10 individuals in this protocol, exacerbations of 
respiratory or non- respiratory problems may occur. Should exacerbations of 
disease in any part of the body occur during any part of the protocol the 
subjects will be treated by conventional clinical therapy. During the period 
of illness, assessment of safety and effectiveness of the AdCFTR administra- 
tion will continue as long as such assessment does not interfere 
with the clinical care and welfare of the patient. It is possible that the 
study individual will not be able to continue with the protocol because of 
intercurrent illness. 
l: 
In the event that adverse reactions (bad side effects) attributable to admin- 
istration of AdCFTR or study procedures occur during the protocol, the study 
individual will be treated by conventional clinical therapy. Assessment of 
safety and effectiveness of the AdCFTR administration will continue as long as 
such assessment does not interfere with clinical care and welfare of the 
patient. It is possible that the study individual will not be able to contin- 
ue with the protocol because of adverse effects, although all possibilities 
will be explored to prevent removal from the study, as long as the welfare of 
the study participant is ensured. 
When the study participant no longer has detectable AdCFTR or related virus in 
body secretions on 3 successive determinations, he or she will be able to 
leave the isolation precautions. After completing the approximately 2 month 
post AdCFTR administration evaluation, he or she will be able to leave the NIH 
Clinical Center, provided certain "out-patient" criteria are met. These 
criteria and the effects of these criteria on the individual are discussed in 
section 5.6.4 in the protocol and in an earlier part of this consent form. 
Following discharge from the Clinical Center, the study subject will return as 
an inpatient for reevaluation at various intervals. He or she will be reevalu- 
ated with the same tests as performed during the various parts of the protocol 
(see Table 5. 6. 4-A in the protocol). 
The tests in the baseline period (part 1) include blood tests, urine tests, 
sterility tests (semen analysis in men, ultrasound for the presence of the 
uterus and/or ovaries in women), electrocardiogram, chest X-rays, computed 
tomography scan of the chest (a specialized type of chest X-ray) , ventilation 
and perfusion scan (a test with radioactive molecules to determine the distri- 
bution of air and blood in the lungs), lung function tests, collection of 
sputum, fiberoptic bronchoscopy (to evaluate the air passages, to recover some 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
[784] 
Recombinant DNA Research, Volume 16 
