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The designs presented in this paper match the efficacy objective with go/no-go decisions.
The efficacy objective is to find preliminarily evidence of the effectiveness or ineffectiveness of study treatments.
Primary efficacy objective was the reduction of the muscle tone measured by Ashworth scale.
Binary primary endpoints including both tolerability and efficacy (objective response and long-lasting stable disease) are warranted.
Interestingly, in this latter trial, the efficacy (objective response and survival) was more enhanced.
Assessments included safety, pharmacokinetics, pharmacodynamics and preliminary efficacy (objective response rate (ORR)).
Similar(40)
The predefined primary efficacy objectives were the decrease of antibiotic consumption, reduction of inappropriate antibiotic (ATB) use and antimicrobial resistance.
The efficacy objectives of this study are to compare overall survival (OS) (primary endpoint), progression-free survival, and response rates between the 2 treatment arms.
First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved.
The efficacy objectives of this study are to compare overall survival (OS), response rates, disease control rates, progression-free survival, and time to progressive disease between the 2 treatment arms.
The coprimary efficacy objectives of this study are progression-free survival (PFS) and overall survival (OS); secondary objectives are overall response rate, changes in patient-reported pain and disease-related symptoms, changes in health status, resource utilization, safety and tolerability, and pharmacokinetics/pharmacodynamics.
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