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We defined a major adverse limb event (MALE) as a key endpoint for revascularization therapies in CLI inclusive of amputation (transtibial or above) or any major vascular reintervention (thrombectomy, thrombolysis, or major surgical procedure [new bypass graft, jump/interposition graft revision]) in the index limb.
The Cochrane systematic review of lactate measurement in labour identified the caesarean section rate as a key endpoint for the evaluation of this form of fetal welfare assessment [ 2].
The high pre-vaccination seropositivity supports use of defined VRs as a key endpoint of the study, since it measures the percentage of participants that had a response to vaccination, rather than simply seropositivity.
The Seattle Angina Questionnaire (SAQ) [ 3] is a coronary disease-specific patient reported outcome measure (PROM) that has been included as a key endpoint in numerous clinical trials of stable coronary disease [ 4- 9].
However, currently it is not used as a key endpoint by regulatory agencies, since it has only recently been confirmed as a relevant endpoint, and there are few exposure/response studies available.
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All studies assessed ARR or time to first relapse as the primary endpoint and time to 3-month confirmed disability progression as a key secondary endpoint.
On the basis of this unprecedented finding, tophus reduction or resolution was evaluated as a key secondary endpoint in two replicate, randomized, six-month, double-blind, placebo-controlled phase III trials of pegloticase in patients with chronic gout refractory to conventional therapy.
In further support of Day 7 as the key endpoint for this meta-analysis untreated HK can take up to three weeks to resolve making resolution within a week a therapeutic success, and many of the original idoxuridine studies utilized a day seven endpoint in their analyses [ 6, 10].
Such frontline treatment defines pathological complete response (pCR, absence of infiltrating tumour in breast and lymph nodes) as the key endpoint, predicting long-term survival especially in patients with ERA-negative or TN tumours (Liedtke et al, 2008; von Minckwitz et al, 2012b).
In clinical trials of therapies for CD, the CD-PRO/SS potentially can provide data for a co-primary endpoint or a key secondary endpoint.
In clinical trials of therapies for UC, the UC-PRO/SS potentially can be used to collect data for a co-primary endpoint or a key secondary endpoint.
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CEO of Professional Science Editing for Scientists @ prosciediting.com