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The mechanism involves TGF-beta 1, a marker we measure in Chronic Inflammatory Response Syndrome (CIRS)

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The lethal dose in humans would be approximately 21,000mg for a 70kg person, making the 1-3mg daily doses used in typical protocols extremely safe from a toxicity standpoint

There was a positive trend in the Composite SLE Responder Index in the Intention-to-treat (ITT) cohort, and post-hoc analysis showed that the BILAG secondary endpoint was met for a number of subgroups dosing levels, including low or no steroids, seropositivity, and patients with 2 grade BILAG improvement