1. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1–33). Available on the web: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2004_726_cons/reg_2004_726_cons_en.pdf (last access February 6, 2009).
2. Limits of add-on trials: antirheumatic drugs;Ottolenghi;Eur J Clin Pharmacol,2009
3. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial;Zinman;Ann Intern Med,2007
4. DHHS Food and Drug Administration. 21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule 28 April 2008, effective, October 27 2008. http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480537f08 (last access June 1st, 2009).
5. Does the FDA have the authority to trump the Declaration of Helsinki?;Goodyear;BMJ,2009