CHMP finder ikke, at den manglende signifikante forskel for to af de tre komponenter af det sammensatte endepunkt i EUROPA- undersøgelsen giver grund til at begrænse indikationen til en enkelt komponent, eftersom der ses en positiv og fuldstændig konsistent tendens for disse to komponenter.
The CHMP believes that the lack of a statistically significant difference for two of the three components of the composite endpoint in the EUROPA study is not a reason to restrict the indication to a single component, given that a positive and fully consistent trend for these two components is observed.