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MP contributed to the conception and design of the study, applied for ethical approval, collected data and is the main interpreter of the data, drafted and approved the submitted manuscript.
BE designed the study, obtained ethics approval, collected and provided patient data, and wrote the patient information section.
PB obtained ethics approval, collected and analysed data, and drafted and revised the manuscript.
Ms. AHP designed the study, obtained ethics approval, collected and analyzed the data, created initial manuscript draft and subsequent revisions.
MR contributed to the design of the study, acquired ethical approval, collected data, and commented on the manuscript.
SB contributed to the design of the study, acquired ethical approval, collected data, and commented on the manuscript.
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Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives.
Appropriate ethics approval was collected from the Ethics Committee at Manchester Metropolitan University, the National Heath Service and the National Research Ethics Service.
MDG contributed to the concept and design of the study, interpreted and analyzed the data, contributed critical revisions and intellectual input, gave final approval, and collected and assembled the data.
With appropriate ethical approval, information collected from the Africa Centre surveillance activities were linked to information collected in the Treatment and Care Programme and those that met the criteria for groups 1 and 2 were randomly selected and approached for informed consent.
This resulted in retaining cases enrolled with ED operational approval until NH operational approval to collect data was received.
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