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No anaphylactic or other severe reactions were reported to occur within 30 minutes after any dose of study vaccine.
Subjects in both studies who received any dose of study drug were included in the safety analyses.
Analysis of safety data was carried out on the safety population (all subjects who received any dose of study medication).
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The three participants who were randomized but not treated all withdrew their consent after randomization, but prior to receiving any doses of study drug.
Administration of any vaccine unforeseen by the study protocol within 14 d before any dose of the study vaccines or concurrent participation in other clinical studies were reasons for exclusion.
A total of 63 patients met entry criteria and received a dose of study medication.
Two other patients were registered but did not receive a dose of study drug at all.
Safety analyses included all patients who received any dose of blinded study medication.
Any subsequent dose of study medication was for the emergence of a new target breakthrough pain episode and not an unresolved previously treated episode.
Patients who received empagliflozin over 90 weeks (any dose of empagliflozin during study 1 or 2, 10 or 25 mg during the extension trial) showed clinically meaningful reductions in HbA1c, FPG, body weight, and waist circumference at week 78 of the extension study compared with baseline of the preceding trial (Table 2).
For patients receiving 500 μg darbepoetin alfa and who had an increase >10 g/l in haemoglobin concentration in any 2-week period, the dose of study drug was reduced to 300 μg using the most recent dosing frequency.
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CEO of Professional Science Editing for Scientists @ prosciediting.com