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Variables that showed significant associations were used as the basis for group allocation of the children.
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Three research assistants blinded for group allocation collected all data.
It was not possible to blind professionals for group allocation.
The nurse and the parents are blinded for group allocation.
One of the assessors (MG) was blinded for group allocation.
The first data analyzes were performed blinded for group allocation.
Neurosurgeons will be blinded for group allocation, as randomisation and group allocation is performed after their involvement in participant recruitment.
All patients were blinded for group allocation and data analysis was carried out without knowledge of group allocation.
During data analysis, the statistician was blind to group allocation by the use of mock codes for group allocation (0,1).
The use of an off-site computerized website for group allocation will decrease the risk of allocation bias.
Personnel responsible for assessments of secondary endpoints were not blinded for group allocation.
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