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Patients who had failed screening for other GSK trials on the basis of not meeting the eligibility criteria for asthma or COPD were targeted for recruitment.
To report the outcomes of full ophthalmic examination for preschool children in LA County who failed screening with the Retinomax Autorefractor.
11 Mean ± standard deviation enzyme concentrations and changes in concentrations from screening to baseline were summarized for each subject population, separated by subjects who failed screening (screening data only) and subjects who did not fail screening who were randomized (screening and baseline data available).
Five patients failed screening.
Two subjects failed screening.
6 Because these subjects failed screening to enter the phase 2b clinical trial, a G6PD genotyping sample was not taken.
Subsequently a total of 187 patients failed screening or dropped out due to personal reasons prior to treatment allocation.
The proportion of subjects with elevated enzyme levels (>ULN) at screening was similar in subjects who failed screening and subjects who were randomized in each study.
In addition, two patients failed screening, one because of renal impairment (CrCl <30 ml/min) and one because the blood film revealed unexpected relapse.
A correlation analysis between HbA1c and each pancreatic enzyme was also conducted by analyte and visit, separately for subjects who failed screening and subjects who were randomized.
The ICS doses had to remain stable during the screening period; patients who failed screening for this reason could be re-screened if the ICS dose had been stable for 1 month.
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