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The patient with heart failure died of the event before the fourth study drug injection.
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All men and women aged 15 to 49 years who slept in a selected household the night before the first study visit were eligible for study participation.
Children were excluded as well from participation if BCG vaccine had not been given at least one week before the first study vaccination or if any other vaccinations, other than the first dose of oral polio vaccine (OPV) given at birth with BCG, had been given prior to enrolment.
If sensor failure occurred before the third study day (the CRC visit) the sensor was replaced.
A bone scan was also performed within 6 weeks before the first study treatment.
All DMARDs were discontinued ≥4 weeks before the first study agent administration.
Subjects attended a screening visit, performed 1 2 weeks before the first study day, to confirm eligibility.
Physical activity is again measured by accelerometer for seven days in the week before the second study visit.
Pertinent eligibility included written informed consent before study entry, Eastern Cooperative Oncology Group performance status of 0 or 1, and no radiotherapy within 3 weeks before the first study drug infusion.
The questions were mostly formed before the first study in 1988 by the study group, although some new questions were added in later questionnaires.
Of these, 30 patients received at least one dose of the study drug, while 1 patient randomized to C.E.R.A died before the first study drug was administrated.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com