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We would also recommend that in main studies characteristics associated with wear-time are further explored and their likely impact on the validity of results assessed through appropriate sensitivity analyses.
The concentration of free Mg2+ used was 1 mM and not 10 mM as in main studies with APH(3′ -IIIa because 1 mM is rarely inhibitory with kinases and is probably close to the in vivo level [17].
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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.
More than 3000 patients have received PTH in the main studies.
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.
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