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Methods: Records from Guidant/EVT clinical trials and postmarket approval databases from February 1993 to August 2000 were analyzed to identify patients with rupture and to extract pertinent data.
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From the new product approval database, we extracted the new product approval date.
We searched the publicly available FDA premarket approval database (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm) on 1 August 2012 for all devices meeting the following parameters: "Cardiovascular" under advisory committee and "Originals Only" under supplement type, with an FDA approval date between from 1 January 2000 to 31 December 2010.
Ethics approval for database access was received from the University of Saskatchewan Biomedical Research Ethics Board.
The study protocol received approval for database research from the Independent Scientific Advisory Committee of the Medicines and Healthcare Products Regulatory Agency (United Kingdom).
Drugs were categorized as orphan drugs using the FDA's monthly drug approval reports database and the FDA's orphan drug list.
22 Briefly, we scoured the Drugs@FDA monthly drug approval reports database (including original new drug approvals and biologic license application approvals) and the FDA's annual reports summarizing new molecular entities and new biologics spanning 1999 to 2014.
All final cleaning checks have been performed and all outstanding issues resolved Approval for database lock has been obtained from the Head of Data Management (HoDM), the statistician, and the PI.
JM formed the original study design and clinical database, obtained the ethics approval and obtained database funding.
Demographic characteristics, obstetrical history, pregnancy and neonatal data were registered prospectively in hospitalization databases (approval by CNIL, the French Data Protection Authority, under the notification number 1181076).
Following a formal request to review the ELSO registry database, approval was granted from the Protocol Chairman of ELSO Registry Committee.
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