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godkendelsen bygger på resultaterne af dosistitreringsundersøgelser og en multicenter -feltundersøgelse.
the approval was based on the results of dose titration studies and a multicentric field trial.
prevenars immunogenicitet er blevet undersøgt i en åben multicenter undersøgelse med 49 børn med seglcellesygdom.
the immunogenicity of prevenar has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease.
det er en prospektiv, multicenter -, randomiseret klinisk fase-iii -undersøgelse.
it is a prospective, multicentre, randomised phase iii clinical trial.
triton var et internationalt multicenter, randomiseret, dobbeltblindt, parallelgruppeforsøg med 13.608 patienter.
triton was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde, basale kliniske undersøgelser:
the efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies:
ris formålet med det tredje multicenter, dobbelt- blind, randomiserede studie var at undersøge effekt og
there were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the clinical trial.
to fase iii randomiserede, multicenter, dobbeltblinde, placebo-kontrollerede undersøgelser er blevet udført hos patienter med cervikal dystoni.
two phase iii randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
den endelige rapport underskrevet af investigator og for multicenter-afprøvninger af alle investigatorer eller den koordinerende (hoved)investigator.
final report signed by the investigator and for multicentre trials, by all the investigators or the coordinating (principal) investigator.
et åbent, randomiseret, non-komparativt multicenter-studie med patienter med behandlingssvigt ved initial behandling med 400 eller 600 mg imatinib.
an open-label, randomised, non-comparative multicentre study was conducted in patients who failed initial treatment with 400 or 600 mg imatinib.
vurderingen af sikkerheden ved subkutan tocilizumab hos ra-patienter inkluderer et dobbeltblindet, kontrolleret, multicenter-studie, sc-i.
the safety of subcutaneous tocilizumab in ra includes a double-blind, controlled, multicenter study, sc-i.