However, the CHMP requested the MAH to undertake an additional study in young rats, to assess the neurohormonal status of hypothalamic-pituitary-gonadal (HPG) axis during sexual maturation of juvenile male and female rats.
CHMP anmodede imidlertid indehaveren af markedsføringstilladelsen om at udføre et supplerende forsøg hos unge rotter til vurdering af den neurohormonale status af hypothalamus- hypofyse- gonade- aksen under kønsmodning af unge hun - og hanrotter.