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E centre trial): D.2.5 Complete below D.2.5.1 Organisation : D.2.5.2 Name : D.2.5.3 Address : D.2.5.4 Telephone number : D.2.5.5 Fax number : D.2.6 E-mail : E SUBSTANTIAL AMENDMENT IDENTIFICATION E.1 Sponsor s substantial amendment code number, version, date for the clinical trial concerned: E.2 Type of substantial amendment 2 3 As stated in Article 19 of Directive 2001/20/EC. According to national legislation. Substantial Amendments Form October 2005 2/6 E.2.1 E.2.2 E.2.3 E.2.3.

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