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References<br />

• Aronson JK, Hauben M. Anecdotes that provide definitive evidence. BMJ 2006; 333; 1267-9<br />

• Bradford Hill A. The Environment and disease: association or causation Proc Royal Soc Med 1965; 58, 295-300<br />

• Naranjo CA, Busto U, Sellers EM, Sandor P et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (2): 239‟45<br />

• Taofikat B. Agbabiaka TB, Savovi J, Ernst E. Methods for causality assessment of adverse drug reactions. A systematic review. Drug Safety 2008; 31 (1): 21-37<br />

• Guidelines for preparing core clinical safety information on drugs. 2 nd Ed. Report of CIOMS Working Groups III and IV. CIOMS Geneva 1999<br />

• Management of safety information from clinical trials. Report of CIOMS Working Group VI. CIOMS Geneva 2005<br />

• EMA: Guideline on good pharmacovigilance practices (GVP); Module IV ‟ Management and reporting of adverse reactions to medicinal products, 20 February 2012;<br />

EMA/873138/2011<br />

• FDA: Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies. Sep. 2010 Drug Safety<br />

• FDA: Federal Register/Vol75, No 188/Wednesday, September 29, 2010/Rules and Regulations p59945

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