1. ICH Expert Working Group ICH harmonised tripartite guideline: choice of control group in clinical trials (E 10) [online] 2000 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf
2. Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) Food and Drug Administration, U.S. Department of Health and Human Services Guidance for industry non-inferiority clinical trials [online] 2010 http://www.fda.gov/downloads/Drugs/Guidances/UCM202140.pdf
3. Some essential considerations in the design and conduct of non-inferiority trials;Fleming;Clin Trials,2011
4. Good enough: a primer on the analysis and interpretation of noninferiority trials;Kaul;Ann Intern Med,2006