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A power calculation performed before the study, using Ea/Ees, indicated that 21 participants were required for each group.
Interviewers were trained for two weeks before the study using practical exercises and were supervised twice weekly by the researchers (ECO, CON) and the district TB control supervisors.
The reliability of these measurements was evaluated before the study using the CAIx intra-class correlation coefficient (ICC), which showed values of 0.97 (95% CI: 0.94-0.99) for intra-observer agreement in repeated measurements of 22 subjects.
Severity of illness was assessed in each patient immediately before the study using the Acute Physiology and Chronic Health Evaluation II scoring system [ 16, 17], and empirical criteria for the diagnosis of sepsis [ 18- 20] were used.
Recorded sounds coded for each infant were retrospectively evaluated by three medical doctors working in the neonatal intensive care unit and trained before the study using a computer aided instruction on respiratory sounds (R.A.L.E.® Lung Sounds 3.2).
Noninferiority was defined before the study using the criterion agreed on between Novo Nordisk and the U.S. Food and Drug Administration FDAA) for the detemir phase 3 study program, namely, a difference in A1C between groups of <0.4% A1C (12).
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The monthly incidence of resident falls was monitored for three months before and throughout the study using data from the managers' falls logs at each site.
Participants will be asked to state the average number of hours they spend exercising in an average week before involvement in the study using the General Practioner's Activity Questionnaire.
A power analysis was done before the start of the study using Oxycodone consumption as the primary endpoint.
A power analysis was done before the start of the study using morphine consumption over 48 hours postoperatively as the primary endpoint.
The reliability of the measurements was evaluated before the start of the study using the intraclass correlation coefficient, which showed values of 0.97 for intraobserver agreement on repeated measurements in 20 subjects, and 0.89 for interobserver agreement.
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