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Statistical Consideration

AS Apresh Singla
SL Sarah J Lord
QN Quan Ngo
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Sample size was calculated on the basis of a type I error of 5% (ie, P <.05) and a type II error of 10% (ie, power of 90%) with the aid of a statistician. Using formal sample size calculations we estimated a sample size of 250 patients for each treatment group. We anticipate an attrition rate of 10%, and subsequently, have increased our sample size by that amount for each treatment group.

Statistical analysis will be carried out by an external statistician. We intend to use independent two-sample t tests on primary endpoints and both chi-squared and independent two-sample t tests on secondary endpoints.

Copyright and License information:  ©2016 Apresh Singla, Sarah J Lord, Quan Ngo. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.07.2016.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

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