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Seven patients were included but did not receive study drug (2 because of physician decision, 2 patient decision, 2 deaths, 1 entry criteria violation).
Three withdrew consent for personal reasons, one discontinued treatment because of adverse side effects and one had a protocol violation (inclusion/exclusion criteria violation).
Originally, 176 patients were enrolled in the study, after which 1 patient was excluded because of an enrollment criteria violation, and thus a total of 175 patients were randomized into two groups to receive omeprazole or placebo.
Five patients were excluded because of discontinuation before the first dosing for the following reasons: withdrawal of patient consent (n=2), chemotherapy regimen cancelled (n=1), patient eligibility criteria violation (n=1) and a positive result in the skin test to EPO (n=1).
mITT comprises all randomized patients with the exception of patients for which it is obvious at the time of randomization that no study specific therapy would be applied, while PP analysis assesses mITT patients who do not meet any of the following criteria: violation of inclusion and/or exclusion criteria, major deviations from the visit schedule, and bad compliance during feedback sessions.
The per-protocol set (PPS) included the patients from FAS who did not meet the following conditions: (1) inclusion criteria or exclusion criteria violation; (2) use of prohibited concomitant medications; (3) administration of the study drug less than three times; (4) failure to undergo the examinations required to determine the clinical effect; and (5) poor compliance with the study drug.
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Furthermore, a relatively high number of patients (9 patients) were excluded for eligibility criteria violations, mostly RECIST criteria violations (data not shown).
Criteria violations leading to exclusion are listed in the online supplementary material.
A limitation was that a relatively high number of patients (9 patients) were excluded for eligibility criteria violations.
Now, a bill pending before the City Council would require board members to sign a statement saying they did not discriminate on the basis of race or other criteria, in violation of fair housing laws, when rejecting applicants.
A total of 332 children were included in the final analysis; 25 were excluded due to not meeting the inclusion/exclusion criteria (protocol violation) in two cases and failure to either collect or analyse the stool samples for RV in the remaining 23 children.
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