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This trial requires the recruitment and consent of women in labour.
This trial requires no specific tests or procedures that are not regularly performed.
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Thus, this trial required multiple sites and intensive community outreach efforts to promote couples counseling with strong linkages with HIV-1 voluntary testing and counseling centers, antenatal clinics, and other clinical and community organizations.
Finally, this trial required normal renal function at entry.
This trial required separate sample size calculations for the prerandomisation and postrandomisation phases of the study.
However, this trial required a second insulin formulation for persistent hyperglycemia.
This trial required informed consent and was conducted under the approval of the Duke University Institutional Review Board.
Calculating costs for this trial required sourcing cost data from multiple sources including funders no longer involved with the trial.
The cluster-randomized design of this trial required a recalculation of the sample size compared to the study protocol [ 34].
Participation in this trial required a paediatric registrar onsite 24-hours and nursing staff trained in use of CPAP for neonates.
In order to have 90%% power to detect this change with an overall two-sided type I error rate of 5%%, this trial required a total of 60 subjects, or 30 for each group.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com