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Key exclusions were active GI ulcer hemorrhage or gastroduodenal ulceration within 90 days of screening, known established cardiovascular disease, any patient who, in the opinion of the investigator, was at sufficiently high cardiovascular risk to require low-dose aspirin, or positive fecal occult blood test at screening.
Other key inclusion criteria were age at least 18 years; ECOG performance status of 0 1; and any lactate dehydrogenase level, regardless of b-raf mutation status or HLA type; key exclusions were brain metastases (based on imaging) and symptomatic autoimmune disease.
Key exclusions were for pre-existing sustained severe hypertension (≥180/110 mm Hg while sitting), atrial fibrillation or other significant cardiac arrhythmia, current use of tricyclic antidepressants or other norepinephrine reuptake inhibitors, current use of antihypertensive medication (except short-acting agents at bedtime), or use of vasoconstrictive agents within 2 days before baseline.
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Other key exclusion criteria were significant head trauma, known or suspected cardiac/cardiovascular disease, and current implantation with electrical or neurostimulation devices or metallic hardware.
Key exclusion criteria included the use of any other anticancer agent or investigational agent within 4 weeks prior to the start of sunitinib treatment, prior specific anti-vascular endothelial growth factor (VEGF) treatment, and any condition requiring treatment that was likely to affect the reliability of the serial PET assessments.
The key exclusion criteria in the four studies were a current depressive episode >12 months' or <4 weeks' duration at enrollment; an Axis I disorder diagnosis other than bipolar disorder; ≥8 mood episodes in the preceding 12 months (except BOLDER I); a HAM-D Item 3 score ≥3, posing a serious suicidal or homicidal risk (as judged by the investigator), or attempted suicide within the past 6 months.
Key exclusion criteria were: severe malaria, treatment with MQ in the 60 days prior to screening, treatment with DHA/PQP in the 3 months prior to screening and >4% parasitised red blood cells.
Key Exclusion Criteria.
Key exclusion criteria are outlined in e-Appendix 1.
The key exclusion criteria are listed in Table 2.
The key exclusion criterion common to the four registries was concurrent participation in a clinical trial.
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