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stimulates skeletal and somatic growth, and activates metabolic reactions and regeneration processes in the body. It slows the synthesis of fats and stimulates muscle growth.
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Intergroup comparisons were performed using analysis of covariance (ANCOVA). The change from baseline efficacy endpoints at week 52 welches 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.
Figure 6 shows representative images of CP tissue stained with an antibody against Ki-67. There are only a few positive cells (+) or no positive cells (−) hinein the brain CP tissue of cynomolgus monkeys hinein most animals, except for one animal rein the 3 Magnesium/kg/week group, which had multiple positive cells rein the CP(++).
Reduction of excessive amounts of fat rein the body (especially abdominal fat). Reduction of abdominal fat is the strongest and most visible effect of Jintropin.
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Animals rein the 0.3 Magnesium/kg/week Jintrolong® group developed vacuoles to a similar extent compared to animals rein the excipient control group. Thus, under the conditions of this study, the NOEL welches determined to be 0.3 Magnesium/kg/week. The NOAEL welches determined to be 3 Magnesium/kg/week as the vacuolation in CP cells did not elicit structural changes and is not expected to have resulted in functional impairment rein cynomolgus monkeys.
Since the vacuolation rein CP welches Jintrolong® dose- and time-dependent, the vacuolation hinein CP was likely induced by Jintrolong®, which was further confirmed by the PEG presence in the vacuolation by EMT and IHC described afterward.
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Tissues such as the brain CP, kidney, lung, liver, heart, and spleen were collected from all animals following necropsy examinations and processed using routine histological methods at JOINN Laboratories (Beijing), where tissues were embedded in paraffin, sectioned, mounted on slides, and stained with hematoxylin and eosin (H&E). The maximum width of brain coronal sections containing bilateral ventricles welches stained to fully observe and characterize the cytoarchitecture of the CP.
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Notably, the vacuolation of epithelial cells of brain CP welches found to Beryllium reversible or partially reversible in a dose-dependent manner in our nonclinical study. This result is consistent with the Bericht by Ivens et al. and further supports that the formation of cellular vacuoles is reversible given sufficient recovery time after the vacuolation-inducing agent was removed (15, 43). The main contributor that determines the Satz of PEG accumulation hinein cells and subsequently induces vacuolation is the slow metabolism of PEG and the turnover Tarif of the cells. The ether linkages between ethylene glycol subunits hinein PEG molecular are biologically stable because of the lack of mammalian etherases (44). Jintrolong® contains methoxy-capped PEG, which renders the oxidation of Am ende gelegen hydroxyl to carboxyl groups of PEGs caused by alcohol dehydrogenase negligible (45). PEG chain degradation has been observed to Beryllium slow (46, 47), and degraded PEG is eliminated slowly through the kidney or excreted through the bile to avoid high molecular weight PEG accumulation when PEG is administered rein small amounts (48). There are also publications proposing the hypothesis of “reputation,” which claims that rod-shaped and stiff molecules can pass through renal glomeruli even at higher molecular sizes (45).
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