Sikkerheden og virkningen af Replagal blev vurderet i to randomiserede, dobbeltblindede, placebo - kontrollerede studier og åbne ekstensionsstudier i 40 patienter i alt med en diagnosticeret Fabrys sygdom baseret på klinisk og biokemisk evidens.
The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.