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The goal of phase I clinical trials is to estimate the maximum tolerated dose (MTD), the highest dose at which a specified probability of toxic response is not exceeded.
The MTD was defined as the highest dose at which less than one-third of the patients experienced DLT.
The MTD was defined as the highest dose at which none or one out of six patients developed a DLT.
The MTR was defined as the highest dose at which no more than one in six patients experienced a DLT.
The MTD was defined as the highest dose at which six subjects were treated with at most one subject experiencing a DLT.
The MTD was defined as the highest dose at which at least three of six patients had dose-limiting toxicity (DLT).
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Average area under the lactulose/mannitol time curve: 5.36 (SE 0.08) in controls vs 3.97 (SE 0.07) in the high-dose AT-1001 group, p<0.05.
Subsequent cohorts contained both chemotherapy naïve and post-chemotherapy men, with only the post-chemotherapy men receiving the highest doses at 480 and 600 mg/day.
Toxicity was first tested at a high dose at 7 and 10 days.
Appetite ratings were decreased when compared with control at 60, 90 and 120 min after the high dose, at 90 and 120 min after the intermediate and at 120 min after the low dose (P<0.05; Table 2).
Furthermore, significantly lower blood glucose levels were observed after the high dose at 30, 45 and 60 min, intermediate at 60 min and low dose at 45 min (P<0.05) compared with control.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com