Denne indikation er baseret på effekt - og sikkerheds- data fra to dobbeltblindede, placebokontrollerede undersøgelser af 48 ugers varighed hos behandlingserfarne patienter (se 5. 1).
This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials of 48 weeks duration in treatment-experienced patients (see section 5.1).