Suggestions(1)
Exact(2)
For deltamethrin, the direction of fold-change for c-fos and Egr1 is down in most dose groups measured by qRT-PCR.
Dose proportionality of macitentan pharmacokinetics was only explored by comparing log-transformed Cmax values using a power model described by Gough et al. [ 12], as for most dose groups no reliable estimate of AUC0−∞ could be determined because of the unexpected long t1/2 of macitentan.
Similar(58)
Because the numbers in this subgroup were too low for estimation, a detailed description was prepared for this upper-most dose group (22 cases and 19 controls).
Baseline demographic and clinical characteristics for all trial participants are summarized in Table 2. Overall, ADVAX delivered by standard IM injection or by EP was safe and well-tolerated, although most volunteers in all dose groups reported mild-moderate local pain and/or tenderness.
Most inpatients received concomitant antibiotics with daptomycin in the three dose groups; those most commonly used for inpatients included carbapenems, penicillins, and cephalosporins.
Our predicted releases (Figure S2) as compared with measured release were most accurate within the lowest dose groups.
The percentage of patients experiencing AEs were similar between dose groups in most body system organ classes.
Nevertheless, the small numbers of participants exposed at high cumulative doses (≥ 0.5 Gy) drive the observed trends in most cohorts with these higher dose groups (Table 1).
The differences in mean baseline CSF Aβ levels observed between the dose groups were most likely due to chance resulting from the small sample size.
At least one dose reduction was required in 6/10, 8/10 and 10/11 patients in the 300, 400 and 500 mg dose groups, respectively, and most reductions were of one dose level; two patients in the 400 mg group had two dose reductions to 200 mg, and one patient in the 500 mg group had three dose reductions to 200 mg.
There were no differences in AEs among the dose groups, with the most frequent nonhematologic AEs being nausea, fatigue, vomiting, diarrhea, constipation, bone pain, urinary tract infection, and peripheral edema.
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