I betragtning af ovennævnte punkter var nogle medlemmer af CHMP af den mening, at endometrie - sikkerheden ved Activelle 0, 5 mg/ 0, 1 mg ikke kunne understøttes af KLIM/ PD/ 7/ USA- forsøget.
Taking into account the points above, the some CHMP were of the opinion that endometrial safety of Activelle 0.5 mg/ 0.1 mg could not be supported by the KLIM/ PD/ 7/ USA trial.