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Adverse events will be assessed and reported for safety evaluation.
Descriptive statistics (including mean, median, standard error, ranges for continuous data and frequencies and percentages for categorical data) were reported for safety and pharmacokinetic analyses.
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Safety results are reported for the safety population (n=189) defined as all randomized patients who received at least one dose of study treatment and for whom follow-up safety data are available.
Significantly different means were reported for patient safety grade with all patient safety composite scores.
Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations).
It should be noted that DAS28-based remission (DAS28 <2.6) rates were reported only for safety failures, making it impossible to compare the three groups based on this response criterion.
Safety was reported for all 1138 enrolled patients, and no new or unexpected AEs were reported.
Safety was reported for all subjects who received at least one dose of study drug.
So far, the safety profile reported for anakinra in the long run is rather good [ 11- 13].
Safety was reported for all subjects who received at least one dose of chemotherapy.
Safety is reported for each period for all patients who received ≥1 dose of study drug during that period.
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CEO of Professional Science Editing for Scientists @ prosciediting.com