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REFERENCES 1. International Conference on Harmonisation Expert Working Group. ICH harmonized tripartite guideline: guideline for good clinical practice E6 (R1). June 10, 1996. Available at: http://www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_ Guideline.pdf 2. International Conference on Harmonisation Expert Working Group. ICH harmonized tripartite guideline: statistical principles for clinical trials E9. February 5, 1998. Available at: http://www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/ E9_Guideline.pdf 3. Panel on Handling Missing Data in Clinical Trials; National Research Council. The prevention and treatment of missing data in clinical trials. 2010. National Academies Press: Washington DC. Available at: http://www.nap.edu/ catalog/12955/the-prevention-and-treatment-of-missingdata-in-clinical-trials 4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for clinical tri [