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The predefined primary efficacy objectives were the decrease of antibiotic consumption, reduction of inappropriate antibiotic (ATB) use and antimicrobial resistance.
As with the anti-amyloid agents tramiprosate, tarenflurbil and bapineuzumab, the phase II trial of the anti-tangle compound Rember (methylene blue) did not meet its primary efficacy objectives [ 16].
The tarenflurbil phase III program followed a phase II study that (not surprisingly) failed to achieve its primary efficacy objectives, so the risk of a negative phase III program had to be considered substantial; only the post hoc phase II analyses were encouraging.
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Primary efficacy objective was the reduction of the muscle tone measured by Ashworth scale.
The primary efficacy objective was met if the lower limit of the 95% CI on VE was ≥10%.
The primary efficacy objective was to compare weight change from baseline to week 52 in patients receiving postmeal vs. premeal insulin glulisine with insulin glargine as basal insulin.
Regarding our primary efficacy objective, the results of our study indicate that the use of 6% HES 130/0.4 was associated with a significantly lower intraoperative fluid balance.
The primary efficacy objective of this study was to assess the EFS, defined as the time from enrollment to the first observation of disease progression, death due to any cause, or early treatment discontinuation.
In this head-to-head comparison of two GLP-1 receptor agonists, lixisenatide administered once daily achieved the primary efficacy objective of noninferiority to exenatide administered twice daily in terms of HbA1c reduction at 24 weeks.
Lixisenatide once daily achieved the primary efficacy objective of noninferiority to exenatide twice daily in terms of HbA1c reduction from baseline to week 24 (Fig. 1 A ). Mean (±SD) HbA1c decreased from 7.97% (±0.82) to 7.17% (±0.96%) with lixisenatide and from 7.96% (±0.77) to 7.01% (±0.88) with exenatide.
The primary efficacy objective in all three studies is to demonstrate the reduction of LDL-C by alirocumab, in comparison with placebo, as add-on therapy to stable, maximally tolerated daily statin therapy, with or without other LLT, after 24 weeks of treatment in patients with heFH.
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