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Analyses were based on individual patient data in the treated set, which was defined as all patients who were randomized and received at least one dose of study medication, in all Phase 3 studies.
The analyses based on individual patient-level data in the treated set were defined as all patients who were randomized and received at least 1 dose of study medication.
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Histopathological examination revealed no abnormalities in the liver, kidney, and large intestine (Figure 3) or any other tissue (the brain, lung, spleen, heart, stomach and small intestine; data not shown) in the treated mice.
Overall, the endpoint bone marrow data ranged considerably in the treated group (0% 8.0%%, mean 4.4% ±3.1), rendering the difference between treated and untreated groups insignificant (student's t-test, p = 0.13); in contrast, untreated mice exhibited a highly consistent leukemia burden 7.1% ±1.4, suggesting that GDTc therapy did indeed have some influence in the bone marrow (Fig. 6b).
Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain.
No significant difference is observed in echocardiographic data between the treated group and the control group.
Student's t-test was used to determine the significant differences in measurement data between the treated and control tumors.
Table 1 presents the detailed data about content of silver in the treated ramie.
The data for the biochemical parameters in the treated and control rats are presented in Table 4.
EM-2eGFPluc blood levels were not significantly lower in the treated group (data not shown, 0.24% ±0.24 SD in treated versus 0.31% ±0.33 SD in untreated mice).
In addition, no toxicity in terms of blood cell counts, body weight or behaviour was observed in the treated animals (data not shown).
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