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 
STUDY NUMBER: 
CONTINUATION: page _L of 21_ pages 
protocol itself) of you becoming ill during the protocol. In such 
circumstances you may not be able to receive treatment with AdCFTR or to 
continue with the protocol. These possibilities and how they will be handled 
are discussed in section 5.6 of the protocol. 
Inclusion criteria: 
Study individuals must have cystic fibrosis as defined by routine clinical 
criteria (cough, abundant sputum production, recurrent lung infections, etc.), 
a positive sweat chloride test, a genotype of mutations of both CFTR alleles 
(abnormal DNA sequences) of the type "delta F508" (the most common mutation 
known to be associated with the disease) or at least one CFTR allele (one 
portion of the DNA sequence) of the "delta F508" type and the other known to 
be incapable of producing the CFTR messenger RNA (the product of the gene 
within the cell) . 
Study subjects may be either male or female. To be absolutely sure that the 
normal human CFTR gene being administered in AdCFTR cannot be transferred to 
the germ line (that is, the sperm in males and the eggs in females), only 
individuals with absolute proof of sterility (inability to have children) 
will be accepted for treatment with AdCFTR. Azoospermia (no sperm) on semen 
analysis is accepted as evidence of sterility for males while properly 
documented total hysterectomy (removal of the uterus) , and/or oophorectomy 
(removal of the ovaries) is accepted as sterility for women. These criteria 
are specifically intended to ensure that should the AdCFTR in some unforeseen 
way affect the reproductive cells there would be no transmission (inheritance 
to a child) of new or altered genes. 
All subjects should have antibodies against adenovirus type 5 in their blood. 
This is a safety precaution so that in the event of movement of AdCFTR, or 
related adenoviruses, into the bloodstream the natural defenses of the body 
will be ready to neutralize them. 
All study subjects must be 21 years or older. This is for two reasons. First 
to be sure that their airways, being fully grown, are of sufficient size to 
allow repeated, safe, sampling via fiberoptic bronchoscopy (see below). The 
second reason is that study subjects, being made aware of all the possible 
risks and benefits of participating in this protocol, can give full informed 
consent . 
Participants in the protocol must have lung disease typical of CF yet have a 
forced expired volume in one second (FEV1; a routine lung function test) of at 
All study subjects should be capable of providing informed consent. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
[776] 
Recombinant DNA Research, Volume 16 
>-0099 
