Extrait

•Participants With Adverse Events by Primary System Organ Class (SOC) [ Time Frame: 4 year extension + core 1 year ] Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product. •Change in Liver Iron Concentration (LIC) [ Time Frame: Baseline of Core Study to End of Extension Study, up to 5 years. ] Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)