CHMP fandt det dog vanskeligt at vurdere virkningen af den udtalte toksiske virkning, der er iagttaget i forsøget med unge dyr, ligesom det er vanskeligt at vurdere relevansen af disse oplysninger for børn og unge.
However, the CHMP considered that the impact of the marked toxicity observed in the juvenile study, as well as the relevance of these data for children and adolescents were difficult to assess.