1 Amendments of Carl SCHLYTER related to 2012/0192(COD)
Amendment 295 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, based on pre-determined primary outcome parameters, taking account of statistical approaches, design of the trial and methodology (including sample size and pre-determined sub-groups allowing for a stratified analysis by age and gender and randomisation, comparator and endpoints);