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Assume that a target sample of n participants has to be recruited over s sequences of allocation with equal sizes, that is, participants are recruited in batches of and immediately allocated to groups.
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Both the participants and the study nurse were blinded for sequence of allocation concealment.
The person undertaking the randomisation was not blinded to the sequence of allocation.
Clear advantages of this procedure are a prompt randomisation and a concealment of the sequence of allocation.
Statistical analyses, sample size calculation and generation of the sequence of allocation were performed at the Lyon University Hospital Department of Biostatistics.
During execution, the program produces a random sequence of allocation using the Rnd function that generates a floating point random number.
To ensure that the sequence of allocation was not predictable, the day on which the intervention, control and attention control was used was randomly assigned using a computer-generated random sequence, prepared by a statistician.
Random numbers were generated by using the computer, using block randomization with a block size of 2 or 4. The random numbers were placed in sealed envelopes, and a serial number was assigned to each envelope according to the sequence of allocation of the randomized number.
The sequence of allocation to either intervention will be concealed and performed by a person not involved in the testing or treatment of subjects in the project according to the random generated computer list and kept in numbered and sealed envelopes.
A sequence of allocations in each stratum was generated using the "ralloc" command in Stata.
The sequence of allocations was generated in blocks of eight or 16 such that the allocation was balanced in blocks.
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