ICH Steering Committee.ICH Harmonised tripartite guideline. Statistical principles for clinical trials. European Union, Japan and USA, International Conference on Harmonisation. Available at: http://www.ich.org/pdfICH/e9.pdf.
2.
NelderJA. Discussion on ‘Consensus and controversy in pharmaceutical statistics’. The Statistician2000; 49: 164–164.
3.
CoxDR. Principles of Statistical Inference Section 8.2, 2006.CambridgeCambridge University Press.
4.
FisherRA. Statistical methods and scientific induction. J Roy Stat Soc B1955; 17: 69–78.
5.
SackettDLRosenbergWMCGrayJAM. Evidence based medicine: what it is and what it is not. Br Med J1996; 312: 71–72.