We describe these challenges, which include design, enrolment and analysis issues.
LKH helped in the enrolment, and analysis of the manuscript.
All participants signed an informed Institutional Review Board approved consent at the time of enrolment allowing analysis of their information and samples for research (Montefiore Medical Center; #07-09-320 and New York University; #11-00439).
Xavier Duval was responsible for laboratory data acquisition, patient enrolment and data analysis and interpretation.
We therefore employed a conservative approach, controlling for the differences between lost and tested participants as well as any difference among the groups on enrolment in the analysis.
The information which has emerged from the analysis of enrolment behaviour following the end of the first round of enrolment has been used to inform the construction of propensity scores [ 39].
Fig. 1 Flow diagram of patient enrolment and primary endpoint analysis.
Based on several enrolment samples, independent component analysis and k-means clustering is employed to extract 16 coefficients from most stable parts of the iris textures.
We discuss several trial design opportunities including candidate predictive biomarkers of statin safety and efficacy and offer solutions to the key challenges involved in the enrolment, follow-up, and analysis of such a trial.
