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The 90-day animal study is the core study for the safety assessment of genetically modified foods in the SAFOTEST project.
Pre-perampanel baseline was calculated over the baseline period of the core study for patients who were randomized to perampanel in the core studies, and over the entire double-blind study duration for patients randomized to placebo in the core studies.
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Learning these topics has been an important pedagogical issue to the core studies for management information systems (MIS) and computer science (CSc) students.
Therefore, we used this study as one of the core studies for our risk/benefit analysis for cardiovascular end points in men.
A prolonged time to decline in antibody titers was detected in the extension studies compared with the core studies for patients who received CAD106 during the core and extension studies.
For liver enzyme assessments, 6-month controlled data were included from the five core studies for 1,170 patients in the control group (placebo + DMARD s)); 284 patients in the methotrexate monotherapy group; 774 patients in the tocilizumab 4 mg/kg + methotrexate group; 1,582 patients in the tocilizumab 8 mg/kg + DMARD group; and 288 patients in the tocilizumab 8 mg/kg monotherapy group.
Table 1 gives an overview of the core study measures for the MentDis_ICF65+ project covering all domains of the ICF (see also Figure 1).
Differences in the baseline values of the core study variables for doctors who stayed until t3 (476) and doctors who dropped out after t2 (81) were not found, with the exception of professional support.
The SF-12 scores showed numerical increases (improvement) relative to core study baseline for all measures (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) at month 6.
We studied the expression of ZAP-70, CD38, and Ki-67 by immunohistochemistry (IHC) on TMAs containing the 40 cases (in duplicate cores) studied for microRNA expression.
Furthermore, the fact that six of the initial 16 centers were excluded for logistical reasons meant that the extension phase was underpowered to detect any difference in renal function: The sample size calculation for the core study estimated a need for 100 patients in each treatment arm to detect a difference in eGFR (Cockcroft-Gault) of 8 mL/min 13.
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