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Corticosteroids have been shown to reduce fertility when administered to rats. Male rats were administered corticosterone at doses of 0, 10, and 25 mg/kg/day by subcutaneous injection once daily for 6 weeks and mated with untreated females. The high dose was reduced to 20 mg/kg/day after Day 15. Decreased copulatory plugs were observed, which may have been secondary to decreased accessory organ weight. The numbers of implantations and live fetuses were reduced. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. In animal reproduction studies, glucocorticoids have been shown to increase the incidence of malformations (cleft palate, skeletal malformations), embryo-fetal lethality (., increase in resorptions), and intra-uterine growth retardation. With hydrocortisone, cleft palate was observed when administered to pregnant mice and hamsters during organogenesis

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1–2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

The issuance of the FDA’s Draft Guidance on Homologous Use of Human Cells, Tissues and Cellular and Tissue-Based Products released on October 28, 2015 has created a number of concerns, particularly as it relates to amniotic tissue and MiMedx. MiMedx issued a press release on October 29 responding to some of the concerns that had developed around this complex subject. However, the Company believes that additional commentary and documentation of this regulatory area is appropriate. Therefore, MiMedx has developed these discussion points related to these particular FDA regulations. In addition, the Company has included the information and facts that support our assertion that we are in compliance with the HCT/P, 21 CFR 1271 Regulations on Homologous Use. We have outlined the information herein, and created links to various FDA, and other independent websites where the reader can easily verify the facts on his or her own.

Over the past two decades, elegant work from Dr. R. Shoemaker and his colleagues has demonstrated unequivocally that biotoxins such as mycotoxins are associated with a broad range of symptoms, including cognitive decline (summarized in [5]). These researchers and clinicians identified a constellation of symptoms, signs, genetic predisposition (HLA-DR/DQ haplotypes), and laboratory abnormalities characteristic of patients exposed to, and sensitive to, these biotoxins. The resulting syndrome has been designated chronic inflammatory response syndrome (CIRS).

The structure of cyclocreatine is fairly flat (planar), which aids in passive diffusion across membranes. It has been used with success in an animal study, where mice suffered from a SLC6A8 (creatine transporter at the blood brain barrier) deficiency, which is not responsive to standard creatine supplementation. [98] This study failed to report increases in creatine stores in the brain, but noted a reduction of mental retardation associated with increased cyclocreatine and phosphorylated cyclocreatine storages. [98] As demonstrated by this animal study and previous ones, cyclocreatine is bioactive after oral ingestion [98] [99] and may merely be a creatine mimetic, able to phosphorylate ADP via the creatine kinase system. [98]

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Over the past two decades, elegant work from Dr. R. Shoemaker and his colleagues has demonstrated unequivocally that biotoxins such as mycotoxins are associated with a broad range of symptoms, including cognitive decline (summarized in [5]). These researchers and clinicians identified a constellation of symptoms, signs, genetic predisposition (HLA-DR/DQ haplotypes), and laboratory abnormalities characteristic of patients exposed to, and sensitive to, these biotoxins. The resulting syndrome has been designated chronic inflammatory response syndrome (CIRS).

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