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As the contents of the small intestine varied with time, VOIs were drawn on each time frame, and where no significant uptake could be identified, the VOI from the nearest available time point was copied to provide a measure of background activity.
Safety data was analyzed and reported on every subject (73 total) at every available time point immediately after initial injection.
Based on the presence or absence of a particular viral variant in the pool of viral quasispecies at the earliest available time point we distinguished de novo (Figure 2C, position 146) and pre-existing (Figure 2C, position 278) viral mutations.
At the first available time point for immunological studies and before initiation of HAART (baseline, BL), all investigated subjects showed a positive, and in most cases robust, HIV-specific CD4+ T cell response (median total response 2,780 SFC/106 CD8-depleted PBMCs; range 315-8646) (Figure 5A).
The remaining 31 patients were documentes as "still alive" at the last available time point.
the date of the documentation as "still alive" at the last available time point.
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For stage 1 analyses: the quality of completion was assessed at all available time points by day and week for the baseline and treatment periods; item distribution was examined at all available time points by day and week for the baseline and treatment periods; and item discrimination was assessed using data collected during the last 2 weeks of the baseline period.
Minimally important difference (MID) analyses were performed on the change in DSQ score from baseline (visit 2) to all available time points after baseline using distribution- and anchor-based methods.
Mean annual decline in post-bronchodilator FEV1 % predicted (%predFEV1)(11) was calculated as a linear regression slope using all available time points.
Status scores refer to the score in each of the available time points (at baseline and every 2 years thereafter).
As an outcome measure, we downloaded clinical diagnoses at all available time points up to 72 months.
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