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CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21.
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Although the fecal IgA measurements in the second study for the 0.02-μg group were not significantly higher than those of the nt group, this dose resulted in significant levels of antibody in all other measures for both studies at least at one sample day before the 20-μg booster as well as by day 54 or 55.
Marrow and blood (T cell) chimerism studies at day +100 revealed that both in the lower-dose Clo groups (groups 1+2) and the higher-dose Clo groups (groups 3+4), the patients had a median of 100% donor (T cell -derived DNA.
For morphological studies at day 3 and 14, nasal epithelium was fixed in 10%% formalin solution.
Eleven animals were subjected to displacement PET studies at day 7 after the MCA occlusion.
Histopathologic studies at day 70 showed no Leishmania bodies, a dense lymphocytic and plasma cellular infiltrate, and fibrosis.
For these pulse-chase studies, at day 0 totals of 10,000, 5,000, or 1,000 BrdU-labeled cells were added per well of a four-well chamber slide and fixed at 4, 6, or 8 days after chase, respectively.
In cell proliferation studies, at day 1 of culture, there was a slightly lower number of cells growing on the polymer and different composite surfaces compared with the positive control (tissue culture plastic).
After therapy, withdrawal tumor growth rates still differed; however, at the end of the study at day 40, the tumor sizes between both groups were comparable again, indicating an increased tumor growth rate in the treated group (tumor growth flare).
The endpoints considered were hospital mortality (3 studies), death at day 28 (3 studies) and death at day 90 (1 study).
Fig. 5 Renogram curves in the second part of the study at day 86.
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