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A prospective, randomized, open-label PROBE design (parallel group with a blinded end point) study was performed in 90 patients with type 2 diabetes inadequately controlled by metformin.
Specifically, we considered the issue of LOAEL sensitivity, the type of irritation end point, study quality, and the duration of exposure for the human LOAEL.
The study was designed as a prospective, randomized, open-label PROBE (parallel group with a blinded end point) study of vildagliptin (50 mg twice daily; vildagliptin group) versus sitagliptin (100 mg once daily; sitagliptin group).
The age-group of 50 to 62 years was chosen to study a relatively healthy population, but with a sufficient risk of CKD and cardiovascular disease for a later end point study.
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Although the probative force of clinical end point studies still is stronger, IVUS is catching up.
The end point studied was the number of patients requiring transfusions.
The available data of observational studies regarding this issue showed no clear picture, and controlled end point studies are scarce.
At present, two major randomised, controlled cardiovascular end point studies are ongoing, the LEADER 26 study and the EXSCEL study, 27 each including approximately 9000 patients.
13 22 This trial will investigate the superiority of combination therapy of IVIG+CsA compared to standard IVIG therapy, for preventing CAA complications, in a prospective randomised, open-label, blinded-end point study.
The relatively small number of RCTs, few overlapping treatment arms, and variability in end points studied make it difficult to formally compare therapies for relapsed/refractory CLL.
Thirty-four of these trials reported benefit in at least one of the end points studied.
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