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In order to facilitate the decision making process of malaria control in pregnancy, we carried out a cost-effectiveness analysis of IPTp with SP based on efficacy results of a trial in which the intervention was tested against IPTp with placebo and women in both trial arms received an ITN.
Specifically, the recently defined "animal rule," allows licensure based on efficacy results of studies performed in well-defined animal models that reflect the human disease (reviewed in ref. 13).
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Dosage adjustments were allowed based on efficacy and tolerability.
The choice of an outcome measure to use as primary will be based in part on efficacy results of this pilot study.
The FDA approved PrEP based on the efficacy results of two studies – one in MSM 14 and the other in serodiscordant couples (sexual partners where one partner is HIV infected and the other is not).
"It's a form of rule based on results, efficacy, not on democratic legitimacy," he said.
Based on the equivalent efficacy results and the lack of serious toxicities, the TTFields therapy device was approved by US FDA on April 8, 2011 for the treatment of recurrent glioblastoma.
The majority of guideline recommendations are based on results from efficacy, not effectiveness studies and therefore are not always useful in clinical practice [ 35].
In 2006, the MTS received an indication for use in pediatric patients with ADHD based on results showing efficacy with 9-h patch wear times in the classroom and community settings (Table 1) [ 32– 32].
This analysis focussed on new medicines with an improved efficacy based on the results of randomised active control trials.
Based on the results of the efficacy studies in the hamster and dog models of dyslipidemia and the desired pharmacokinetic data, the optimized compound 39 was selected for further profiling.
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CEO of Professional Science Editing for Scientists @ prosciediting.com