V15 constitutes the final visit on treatment evaluation. During this visit (besides the usual physical exam and blood samples inclusive of pregnancy tests), the treatment drug must be administered in the clinic under supervision of qualified staff and the time of administration recorded accordingly (for the assessment of the pharmacokinetics). In order to not discontinue iron-chelation, from the day after V15 the patient may resume the pre-study or choose another authorized chelation therapy, under medical advice. During V15 Investigators should never dispense the study IMPs. V16, instead, should be completed one month (± 7 days) after V15 to perform the physical examination with auxology and to record contingent concomitant medications/adverse events.
The DEEP project has received research funding from the European Union under the 7th Framework Programme
