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The estimators we consider are appropriate in main study/hybrid validation study designs, where the latter study includes internal validation and may include external validation data.
Because normality assumption was not fulfilled in main study variables, non-parametric tests (Mann Whitney U rank sum test) were applied for comparisons between study groups at baseline and within repeated measurements.
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Exclusion criteria are reported in detail in the main study publication [37].
An immunological substudy was systematically proposed to patients enrolled in the main study in centers from Paris area.
One in three households included in the main study was randomly selected to be included in the validation study sample.
In the main study, reductions in HbA1c, FPG and PPG were observed with both canagliflozin doses.
Weight and height were self-reported in the Main study but measured in the Collaborative study.
Finally, the questionnaire was pre-tested in 10% of the samples in the main study.
Face and content validity were established in the pilot study and confirmed in the main study.
Selection bias was not observed when participants' characteristics in the main study were compared to those in the present study.
The criteria for inclusion in the study in the primary RP group were the same as in the main study.
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