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This approach has proven efficacy, although often transient, in slowing disease progression and preserving residual beta cell function, particularly in recent-onset type 1 diabetes (sources for the efficacy of immunotherapy, e.g., from the Teplizumab trials)

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In some embodiments, the formulations or compositions described herein have a pH and osmolarity as described herein, and have a concentration of active pharmaceutical ingredient between about 0.01-about 20%, between about 0.01-about 10%, between about 0.01-about 7%, between about 0.01-5%, between about 0.01-about 3%, between about 0.01-about 2% of the active ingredient by weight of the formulation or composition