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As shown in Figure 5, the vacuolation observed by TEM is generally consistent with the pathological findings. As the dose increased, the vacuoles in CP epithelial cells were enlarged, more prevalent, and more likely to contain electron compacts, which manifest as dense black dots (denoted hinein Figure 5 with arrows). These electron compacts are consistent with PEG deposits, as the location and shape of the compacts correlate with the pattern of anti-PEG IHC staining in the CP.

The qua-protocol Satz (PPS) was a subset of the FAS that included all subjects without any major protocol deviations. The FAS welches the main data Serie for the evaluation of efficacy. Both ITT and PPS were analyzed to prevent selection bias. Safety data analyses were performed on a safety Zusammenstellung (SS) that included all subjects who had received the study drug at least once hinein the treatment group and all subjects rein the control group after randomization.

Fundoscopy is recommended hinein order to detect edema of the optic nerve and intracranial hypertension (before and during treatment, hinein case of severe headaches, visual impairment, nausea, vomiting). It is necessary to stop the treatment rein case of intracranial hypertension.

Intergroup comparisons were performed using analysis of covariance (ANCOVA). The change from baseline efficacy endpoints at week 52 was tested for superiority of somatropin to no treatment using least squares mean (LSM) difference. There is evidence of superiority if the 95% confidence interval (CI) for the treatment effect lies entirely above zero. AEs were summarized descriptively by severity and relationship to somatropin.

Jintrolong® measurement by ELISA in CSF was also processed, but no Jintrolong® welches detected except for several samples with mixed blood during the CSF collection process, and the lower Grenzwert of quantification welches 8 ng/ml, while the average Cmax of Jintrolong® hinein the serum concentration can reach 46,290 ng/ml rein high dose group, which indicates that Jintrolong® rein the CSF welches 6,157-fold lower than that in the serum. All these data suggest that Jintrolong® hinein the CSF is quite limited.

This result also supports the fact that the function of the CP epithelial cells rein the blood-brain barriers is intact in these animals.

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