Patients who underwent or will Sample Clauses

Patients who underwent or will undergo HSCT This section refers to patients who have received or are planned to receive HSCT after NI-0501 treatment in a previous NI-0501 clinical study or in a CU treatment protocol. Patients may enter the NI-0501-05 study at any time point after NI-0501 treatment or after completion of the short-term follow-up in the parent study, as applicable. Patients will undergo: • Baseline visit: it corresponds to the first study visit. The date of informed consent signature has to be recorded. If the last visit that the patient underwent in the parent study required all the assessments to be collected at Baseline in NI-0501-05 and occurred within 5 days from Baseline, data collected during that visit will constitute the baseline for the present study, and the visit will not need to be repeated or will be performed only to cover for any missing assessments. The Baseline visit will be combined with any other study visit depending on when the patient enters this study [for example, if the patient enters the study after having already performed HSCT, the Baseline visit will be combined with the relevant post-HSCT follow-up visit]. • Weekly visits pre-HSCT: they have to be performed weekly until HSCT for 4 weeks from the end of NI-0501 treatment. If HSCT occurs beyond this time frame, the additional visits will be performed every 2 weeks until start of conditioning. • Pre-conditioning visit: it should occur up to 3 days prior to the start of conditioning and assessments must be performed prior to the first administration of conditioning drug(s). This visit can be combined with any other follow-up visit before HSCT visit, provided that they are no more than 48 hours apart. • Pre-HSCT visit: it should occur no more than 2 days prior to transplant.
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