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In some embodiments, the treatment cycle includes five days in which the IRM compound is administered and two days in which the IRM compound is not administered.

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Although not evaluated in this study, differences in expression levels of TLRs or other receptors that interact with Leishmania, the maturation stage (), and the functional integrity of permanent cell lines () may account for differences observed in the responses to parasite opsonization elicited in primary macrophages and macrophage cell lines.

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Although treatment varies from pure trichloroacetic acid, cryotherapy to electrodessication, we prefer simple curettage or excisional surgery.

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During the domicile periods of initiation (Day 1), and end of treatment (Day 20-21) visits, serum PK samples are collected predose and at planned time points through 24 hours post dose.

It also allows the caregiver at one month follow-up evaluation an opportunity to prescribe analgesics or, if a very intense reaction occurs, to continue treatment with once daily 5-FU rather than increasing the treatment to twice daily.

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