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The small number of patients, study design and the employment of different statistical methods might explain these variations.
A Written Request is a letter issued by FDA to the holder of the New Drug Application NDAA) that outlines how a pediatric study should be conducted and includes the study population, numbers of patients, study design, outcome measures, format, and time line of submission.
After all the eligible studies were identified, the following characteristics were retrieved from each study: authors, geographic distribution of patients, study design, number of patients, reference test, methods of measurement, cutoff values, and raw data including TP, FP, TN, and FN results.
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2– 11 Authors have drawn varied conclusions, based upon the period of evaluation, type of patient, study design, and outcome measured.
The following data were extracted from each eligible study: first author, publication year, country, participants, interventions, controls, outcomes of patient, study design (PICOS), and other relevant information.
Data collected included patients' characteristics, study design, interventions, follow-up periods and relevant outcomes.
Patients and study design.
EC Patients recruitment, study design.
For further details regarding patients and study design, see the article by Jones et al. (5).
GP: Conducting the main study, recruitment and follow-up of patients NR: Study design and manuscript writing.
SH and TY performed the patient care, study design, data collection, manuscript preparation, and literature search.
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