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Thus, in the base case the model is evaluated over lifetime and hence extrapolates beyond the study duration of the pivotal study.
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Beyond this time point, however, (study duration of 2 years) radiographic progression was minimal and indeed similar in both dose groups.
Because type 2 diabetes is a chronic disorder, study durations beyond 52 weeks may better define the long-term efficacy and safety of canagliflozin.
In the calcium acetate/magnesium carbonate group, the serum phosphate levels could be lowered to the clinically relevant K/DOQI target range already after four weeks of OsvaRen® therapy whereas, in contrast, in the sevelamer hydrochloride group this value remained at a comparatively higher level beyond the total duration of the study and was first achieved in week 24.
This would entail prolonging the duration of our study beyond the duration of the learning phase.
Beyond this, the study has important limitations.
They showed that yolk estradiol-17β remained constant through development until increasing on embryonic day 20, which is beyond the duration of our study.
Parents and patients will be told that all study findings will be handled in strictest confidentiality and that it extends beyond the duration of the study.
Sustainability of this 'higher' standard of care and treatment beyond the duration of the study is a challenge faced by many investigators.
If the results become available ten years later, really, we're opening such a huge box that's potentially without boundaries, and I'm concerned about the responsibility that that might put upon us.' In contrast, one clinician investigator argued if the participant can be traced and recontacted using stored information, the responsibility to inform extends beyond the duration of the study.
One advantage of using a non-study specific CAB is that this allows for a relationship to be established between the CAB and the community that will last beyond the duration of a single study, leading to a greater sense of trust between the two [ 17].
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