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The Cycloset Safety Trial study protocol has been previously published in abbreviated form (11). Patients were recruited from 74 centers across the U.S. and Puerto Rico, including 19 Veterans Affairs (VA) hospitals.
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A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance.
In all the three trials, study protocols recommended that analgesic treatment should have been prescribed on an around-the-clock basis and not only 'as needed'.
Given the exploratory nature of this Phase II trial, the study protocol stipulated that additional evaluations guided by the results might be considered, in particular the correlation between the clinical outcome and anti-nicotine antibody titers could be assessed.
In the SAPiT trial, the study protocol design allowed HAART initiation timing in early-HAART arm to be at the discretion of the physicians.
In clinical trials, the study protocol should define the interval between administration of such substances and the PET study.
Especially the early termination of the German study was rather inopportune [ 5]: while this study performed best in the intervention group, with blood glucose levels closer to the upper limit of SGC than the other negative trials, the study protocol allowed for early termination because of safety.
The use of trial registry records and randomized controlled trial (RCT) study protocols can assist systematic reviewers in evaluating and, possibly, minimizing publication and selective reporting biases.
The entry criteria and trial design of FOXFIRE are sufficiently similar to the SIRFLOX clinical trial (SIRFLOX study protocol, submitted to BMC Cancer, March 2014) for the data from the two studies to be prospectively combined in a statistically valid way to improve the overall utility of both studies in answering the key research questions.
Written informed consent was obtained from all study subjects who participated in the clinical trial, and the study protocol was approved by the Institutional Review Board at each study site.
The implementation of the trial adhered to study protocol.
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