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Published online by Cambridge University Press: 20 January 2017
1 See EMA press release at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/11/news_detail_001662.jsp&mid=WC0b01ac058004d5c1> (last accessed on 22 January 2013).
2 See <http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf> (last accessed on 22 January 2013).
3 See <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/11/WC500099472.pdf> (last accessed on 22 January 2013).
4 See <http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500124536.pdf> (last accessed on 22 January 2013).
5 See <http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001202> (last accessed on 22 January 2013).
6 Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43, as amended.