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The change in trial venue, from the Bronx to Albany, was questionable, but there is no reason to believe that the racially diverse jury did not do its duty properly.
A substantial change in trial methodology for solid tumours has taken place, in response to increased understanding of cancer biology.
Moreover, subgroup analyses excluding patients fed with enteral or parenteral nutrition were not suggestive for a change in trial results (data not shown).
Scores for six SMP-T2D measures improved significantly during Study 2. Multiple regression analysis showed independent associations between change in SMP-T2D measures and change in trial outcomes from baseline to end-of-study.
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In this Review, we discuss how to: define the importance of endpoints; make endpoints understandable to patients; improve the use of patient-reported outcomes; advance endpoints to parallel changes in trial design and therapeutic interventions; and integrate these improvements into trials and practice.
This experience is also influenced by changes in trial circumstances, such as premature discontinuation of a study arm.
Particularly in the primary incentive (Liquid) condition, we observed that changes in trial reward value were associated with a shift in event-related activation dynamics, from a late-peaking (during the response/feedback period) to an early-peaking (during the encoding period) profile.
No changes in trial design were made.
No changes in trial outcomes were made after the start of the trial.
No changes in trial outcomes have been made after trial commencement.
This will be done to investigate changes in trial participants—if any in the process of implementation based on their subjective experience.
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