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No interim analyses will be carried out.
Analyses will be carried out using generalized linear models.
Analyses will be carried out in three samples.
Analyses will be carried out using quantitative and qualitative methods.
Both unadjusted and adjusted analyses will be carried out.
Efficacy analyses will be carried out per randomised patient.
A number of sensitivity analyses will be carried out.
All the analyses will be carried out using SPSS 17.0.
Statistical analyses will be carried out in SPSS.
Analyses will be carried out on intention-to-treat basis.
Additionally, exploratory analyses will be carried out on various associations.
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