# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Division 9.9: Statistical methods: description of the following items:

Extent: E+W+S+N.I.

(a)main summary measures;
(b)all statistical methods applied to the study;
(c)any methods used to examine subgroups and interactions;
(d)how missing data were addressed;
(e)any sensitivity analyses;
(f)any amendment to the plan of data analysis included in the study protocol, with rationale for the change.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/3/division/9/division/9.9 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-9/division-9.9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.