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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.
During execution, the program produces a random sequence of allocation using the Rnd function that generates a floating point random number.
Statistical analyses, sample size calculation and generation of the sequence of allocation were performed at the Lyon University Hospital Department of Biostatistics.
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.
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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.
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.
We assessed the generation of random sequence, concealment of allocation, blinding of allocation and incomplete outcome data [ 23].
*Represents risk of bias based on: sequence generation of allocation; allocation concealment and blinding; + represents low risk of bias, − represents high risk of bias, and ± represents unclear risk.
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