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The protocol and consent forms were approved by the Institutional Review Board at each study site before study initiation, all patients signed a written informed consent before enrollment, and the study was conducted in accordance with Good Clinical Practices.
Ten participants reported receiving an antibiotic within 12 weeks of enrollment, 11 others received an antibiotic 12 24 weeks before enrollment, and the remaining 47 had no antibiotic use within 24 weeks.
The low detection rate among healthy controls in our study also might be partially attributable to the eligibility criteria for healthy controls that required a child to be 14 days without AGE before enrollment and the fecal specimen obtained within 5 days enrollment.
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Blood specimens for serologic analysis were obtained before enrollment and at the end of the follow-up period.
At the baseline visit, patients were asked about episodes during the 12 months before enrollment and, at the final visit, about episodes suffered during follow-up.
However, the detailed information regarding exacerbation history before enrollment and subsequently recorded over the course of the study, the large number of patients that participated, and the careful attention to study outcomes provides confidence in the results.
ACE inhibitors, angiotensin II antagonists, and statins were allowed only if they had been taken regularly for >3 months before enrollment and were continued throughout the study.
Pneumonia was diagnosed in patients who presented with a new radiographic infiltrate, exhibited at least two compatible clinical symptoms (body temperature >38°C, productive cough, chest pain, shortness of breath, and crackles on auscultation), had not been exposed to intravenous antibiotics during the 14 days before enrollment, and had not been hospitalized in the last 90 days.
Persons provided written consent before enrollment and providing blood samples, per the human experimentation guidelines approved by BPKIHS and the corresponding body at the Institute of Tropical Medicine, Antwerp.
Tumors were evaluated on the basis of computed tomographic scans and serum carcinoembryonic antigen levels within 30 days before enrollment and every 4 6 weeks after the start of treatment.
All patients received stable drug regimens for at least two weeks before enrollment and drug dosages remained unchanged throughout the study.
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