and lung) . 
The study individuals may go through the baseline period and vehicle control 
period at any time prior to entering the AdCFTR experimental treatment period, 
but if the time between the end of the vehicle control period and beginning of 
the treatment period is greater than 1 month, an additional baseline 
evaluation will be carried out 10 days prior to starting the treatment. 
In the description of baseline, vehicle control, and AdCFTR experiment 
treatment periods that follows, there is an accompanying time chart that 
details the sites of administration of the vehicle or AdCFTR (for the vehicle 
control period and AdCFTR experimental treatment period, respectively) , the 
time of sampling of the nasal and large bronchus epithelia, and the time for 
assessment of various safety and efficacy parameters. A list of the parameters 
within each category and the abbreviations used can be found in section 5.5. 
5.6.2 Baseline Period 
Prior to start of the baseline period, there will be an initial evaluation to 
examine safety and efficacy parameters. This data, plus the data gathered 
throughout the baseline period will determine if the individual is eligible to 
continue in the protocol (see Inclusion and Exclusion criteria, sections 
5.4.1, 5.4.2). If eligible for the remainder of the protocol, the individual 
will enter the vehicle control period within 1 month following the completion 
of the baseline period. Following the initial evaluation, the baseline period 
lasts 30 days (see Figure 5.6.2-A). The baseline period will be used to 
evaluate the reproducibility of various parameters as well as the ability of 
the individual to meet the inclusion/exclusion criteria. 
The specific times for assessment of each parameter may be found in Figure 
5.6.2- A. 
5.6.3 Vehicle Control Period 
The vehicle control period will be to evaluate the same safety and efficacy 
parameters evaluated in the baseline period, except that the vehicle to be 
used in the AdCFTR preparation (10 mM Tris-Cl, pH 7.4, 1 mM MgCl 2 , 3.3% 
glycerol) will be administered to the nostril and bronchi in a fashion 
identical to that in the AdCFTR experimental treatment period. The vehicle 
control period lasts 35 days. The individual must enter the vehicle control 
period within 1 month of completing the baseline period. If the time since 
ending the baseline period is greater than 7 days, there will be a 
reassessment of the safety and efficacy parameters as detailed in Figure 
5.6.3- A. 
5.6.4 AdCFTR Experimental Treatment Period 
The individual will enter the treatment period within 1 month after completing 
the vehicle control period. Prior to the administration of the vector, there 
will be a reassessment of all parameters if the vehicle control period was 
greater than 1 week previously. The individual will then be ready for 
administration of the vector on day 1 of the experimental treatment period. 
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