The acquisition of certain genetic abnormalities: gain 1q, loss 6q, loss 10q/10, loss 13, loss14q/14 and loss 22 appeared distinct from the gains and losses of whole chromosomes that reflect intermediate ploidy, and the characteristics of tumours with these abnormalities were analysed.
Safety endpoints included the incidence of AEs, serious AEs (SAEs), serious infections (SIs) and specific laboratory abnormalities, which were analysed in the safety population (all treated patients with ≥1 postbaseline safety assessment, analysed according to the treatment received).
Safety endpoints included the incidence of adverse events (AE), serious AE, serious infections and specific laboratory abnormalities, which were analysed in the safety population (all treated patients with at least one post-dose assessment of safety, analysed according to the treatment received).
Safety endpoints included the incidence of adverse events (AEs), serious adverse events (SAEs), serious infections (SIs) and specific laboratory abnormalities, which were analysed in the safety population (all treated patients with at least one postdose assessment of safety, analysed according to the received treatment).
All children with abnormalities of the skin were analysed by a paediatric dermatologist who was assisted by residents receiving their training in paediatric dermatology.
The overall number of SSL abnormalities and their type and site were analysed.
A rough differential count of cells was performed on the bone marrow samples to prove the presence of a sufficient number of bone marrow cells and the samples were analysed for haematological abnormalities.
For example, NPC1 and NPC2 mRNA abnormalities should be analysed to establish whether regulatory disturbances and/or cryptic splice mutations might be present.
The mental and psychological dimensions relating to the abnormality and its correction will be analysed for the parents (the importance of prenatal diagnosis, relational development with the child, self-image, quality of life) and also, for the first time, for the child (distress, withdrawal).
HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form.
