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External statisticians were consulted for the statistical analysis.
KH and MG and external statisticians performed and validated the statistical analysis.
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Randomisation was performed by an external statistician in six blocks through a computer program.
Statistical analyses were performed by an external statistician.
A randomisation list is computer generated by an external statistician.
The analysis was performed by an external statistician using SPSS software (SPSS, Chicago).
The analysis was performed by an external statistician using SPSS software version 14.0 (SPSS, Chicago).
Randomisation was completed by an external statistician to limit selection bias.
An external statistician randomly allocated the participants to the intervention group (n = 59) or the control group (n = 53).
Sealed opaque randomization envelopes with a study-specific patient number will be supplied by an external statistician.
Central randomization was performed by external statistician for the 28-week treatment period in a double-blinded manner.
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