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In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated.
Changes to the trial (enrollment, design, outcomes) were not made after initiation of the study.
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The Millennium Cohort baseline enrollment, designed to invite sufficient numbers of women and recent deployers has been shown to be representative in composition of the US military [ 16].
The current article illustrates an approach to conducting power analyses for open-enrollment designs based on the Monte Carlo simulation of LCPMM models using parameters derived from published data from a randomized controlled trial comparing Seeking Safety to a Community Care condition for women presenting with comorbid posttraumatic stress disorder and substance use disorders.
Understanding within-person biomarker(s) change over time is critical for trial enrollment and design.
Beyond these issues, few reference stills are available during enrollment to design representative facial models of target individuals.
Methods, including enrollment, study design, and procedures, have been previously published [ 20].
Enrollment was designed in four arms, ID Pre-Exposure Prophylaxis (Pre-EP), IM Pre-EP, ID Booster, and IM Booster vaccination.
However, these studies have a number of limitations relating to the patient enrollment and study design.
Patient-centered approaches may also be important to ensure adequate intervention design, enrollment, retention, and evaluation of outcomes important to children and their families.
These clinical insights suggest that simulation might offer similar improvements in the design, enrollment, and execution of complex phase 3 clinical research trials.
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CEO of Professional Science Editing for Scientists @ prosciediting.com