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It should be noted that the second dosing-to-first dosing analysis excluded subjects who did not receive or did not complete the second PA dosing due to the occurrence of liver function abnormalities fitting the nonredosing criteria.
As all the necessary toxicology, pharmacology and dosing analysis has already been completed, Phase IV clinical trials to confirm therapeutic use may be more rapidly instigated.
In the dosing analysis further grouping by PMA or PNA was based on the recommendations for the respective antibiotic in the chosen dosing references (Tables 1, 2).
Compared with glargine groups, nocturnal hypoglycemia occurred more frequently in ILPS groups in full studies analysis (0.085 events/patient/30 days, P = 0.022) but not in once-daily dosing analysis (0.06 events/patient/30 days, P = 0.095) (Table 2 and Supplementary Fig. 2).
There also was no statistically significant difference in the event rate of overall hypoglycemia between ILPS and comparators in once-daily dosing analysis (−0.01 events/patient/30 days [95% CI −0.20 to 0.19], with no heterogeneity: I = 23%, P = 0.270) (Table 1) or between ILPS and glargine (Table 2).
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Dose analysis was performed using Monte Carlo simulation.
Each sample was sieved using a 0.84 mm mesh filter for annual dose analysis (300 g).
Overall, benchmark dose analysis estimated a BMDL of 1857 mg/kg/day based on increased serum ALT.
In-phantom dose analysis indicates that the designed epithermal neutron beam can be used for treatment of deep-seated brain tumors in acceptable time of about 70 min.
In-phantom dose analysis indicates that the designed neutron beam can be used for treatment of deep-seated brain tumors in acceptable time.
In-phantom dose analysis indicates that treatment time for a brain tumor is about 40 min which is a reasonable time.
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