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Safety and efficacy considerations are important in optimizing the choice of an antiarrhythmic drug for the treatment of AF.
The dose regimen of anti-OX40L MAb in this study was chosen based on safety and efficacy considerations.
In Europe safety and efficacy considerations fall within the European Medicines Agency Guidelines on Risk Management Systems for Medicinal Products for Human Use[ 22].
These economic, acceptability and efficacy considerations make it imperative that there is further examination into the utility of online therapy for OCD.
This recommendation will be based primarily on safety and efficacy considerations and will be guided by statistical monitoring guidelines defined by the trial safety charter.
No formal interim analyses are intended although the trial's Data Monitoring Committee (DMC) will meet regularly, have access to unblinded data and would recommend early termination to the Trial Steering Committee ifjudged appropriate based on ethical, safety or efficacy considerations.
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Any efficacy consideration in terms of clinically relevant treatment effects, however, implies some knowledge about the incidence of an event with placebo treatment.
The ability of DMTs to reduce markers of disease activity early in the disease course is an important long-term efficacy consideration because the presence of these markers, such as MRI lesion burden and clinical parameters, correlate with severe disability in the long term [ 170– 170].
Considerations of item relevance involved weighing evidence for efficacy against considerations of feasibility given the PRC's jurisdictional context: "If I think back to the smoking one…it was space on the paper if I remember correctly, and you know, "And is there a value in doing it?" … "Is it a 'nice to know', or a 'need to know'?" And is it applicable in this practice setting?
Chapters provide a theoretical basis for PCIT, the empirical evidence for its efficacy, clinical considerations, and training issues.
Inter alia, the terms of reference for UKXIRA instructed the authority to provide advice to government on 'safety, efficacy and considerations of animal welfare and any other pre-conditions for xenotransplantation for human use, and whether these have been met' (UKIXRA 1998, 24).
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CEO of Professional Science Editing for Scientists @ prosciediting.com