Multivariate outliers were screened separately for each planned analysis by conducting a linear regression with participant ID as the independent variable (IV) and all primary outcome dependent variables (DVs) for the planned analysis as the regression DVs.
Data management and planned analysis are ongoing, and release of the results is planned for the end of 2016.
Besides the planned analysis during the dose escalation, no further interim analyses are planned.
Using the example of PA, planned analysis and involved partners are demonstrated in figure 1.
Readers should be made aware of any deviations from the planned analysis.
Software: Specialist software exists for each stage of this planned analysis.
There were no perioperative deaths in the first 30 PEARS patients, who are the subject of this planned analysis.
CPK and JS planned analysis and wrote the manuscript; GB was involved in discussions related to clinical implications.
This paper details the rationale, design, methods, planned analysis and operational aspects of the IMPaCT Back study.
13 The present, prospectively planned analysis aimed to compare AS progression rate and cardiovascular (CV) outcome between women and men during progression of AS.
This study was conducted as a retrospectively planned analysis based on this cohort including patients admitted to our acute stroke unit from March 2009 to January 2015.
