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Although there is a clear regulatory precedent for using this trial design to demonstrate efficacy in RA, it is hoped it will be used progressively earlier in clinical development programs.
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We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322).
This trial design used on off switching following a 3-month baseline data block of normal operations using PAX.
This trial design is used to evaluate interventions whose effects are predicted to be more beneficial than harmful, especially those interventions embedded in daily clinical practice.
Overall we found our methods successful with good compliance, endorsing our use of the MRC Framework and this trial design.
The HUMMER study is designed to provide the best achievable evidence to answer this unresolved problem using an observational trial design.
We considered using a clinical trial design with cluster randomisation at the level of GP practice.
One included trial used a trial design where people knew which treatment they received.
Use a trial design that is appropriate to test your hypothesis.
One obvious parameter to use in trial design and interpretation is the presence or absence of a given nutritional intervention.
We used an adaptive trial design with two cohorts.
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