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The study protocol is available at www.clinicaltrials.gov [ 27], where further details on sample calculation can be found.
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Based on that information, sample calculation generated a minimum sample of 517 dogs (confidence level was 90% and a sample error of 3.5%).
As this was an exploratory physiological intervention study studying multiple hemodynamic parameters, we did not specifically rely on sample size calculation for one single outcome.
Other methodological limitations of many studies include small sample size, and lack of information on sample size calculation or strategies of controlling confounding factors.
Based on sample size calculation for analyses of quantitative data (to detect expected associations), the study period was specified to be from April to May.
More details on sample size calculation and statistical analyses have been published elsewhere [ 4]. Results of the ACUSAR trial have been published previously [ 4].
Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial.
The study was designed to be a pilot, observational one that would enable us to perform later on sample size calculations for a larger study, if needed.
Increased focus on sample size calculations, utilization of registered reports, and presenting information detailing sample size calculations and statistics for future researchers are needed and will increase sample size-related scientific rigor in human electrophysiology research.
Because this is a cross-cultural, simultaneous and original study, it is difficult to rely on literature or sample calculations.
Using this approach, and including a sufficient number of participants based on sample size calculations, we expect to eliminate a bias like this.
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