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The difference of incidence of clinical endpoints will be analysis using Cox-regression analysis.
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Survival analysis techniques will be used by using Cox analysis for binary outcomes and generalised models for continuous variables.
Extracted DNA samples will be used for further analysis using NGS.
SPSS V.21, will be used to conduct analysis using a two-tailed hypothesis with α set at 0.05.
The analysis will be extended using multilevel analysis that takes the nesting of measurements into account.
Data analysis will be performed using the analysis software SAS (version 9.1, SAS Institute Inc ,Cary, USA).
Furthermore, sensitivity analysis will be executed using complete-case analysis.
The analysis will be performed using the primary analysis plan described above.
Data analysis will be conducted using constant comparative analysis, with examination of deviant cases.
This model will be handled using analysis of covariance fitted in SAS using PROC GLM.
If necessary, adjustment for baseline variable will be made, using analysis of covariance (ANCOVA).
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