1. The European Medicines Agency. How we work, http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000125.jsp&mid=WC0b01ac0580028a46; [accessed 13.01.2015].
2. The European Medicines Agency. European Public Assessment Reports: Background and context, http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000433.jsp∣ [accessed 13.01.2015].
3. European Commission. A guideline on Summary of Product Characteristics, http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf; 2009 [accessed 13.01.2015].
4. Principles and practice of clinical trial medicine;Chin,2008
5. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels;Willke;Control Clin Trials,2004