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A secondary sample size estimation was conducted to estimate the number of patients needed for analysing the primary explorative GDI.
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In cases where measurement of QOL is a secondary endpoint, sample size calculations are rare and difficult to establish.
Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered.
For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted.
As a sub-study of a secondary outcome, sample size was determined by the maximum processing capacity of our laboratory and logistical feasibility of data collection; no power and sample size calculations were performed.
For the secondary outcomes the sample size will be too small.
Hence, when we added a secondary pollutant the sample size decreased (Table 5).
Therefore the lack of difference in scores may be secondary to inadequate sample size.
A type II error secondary to inadequate sample size (only nine subjects actually received active dual therapy) might explain the latter result.
To obtain the same level of accuracy in both male and female students as well as in intermediate and secondary schools, the sample size was quadrupled to 3120 students.
To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials.
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