Clinical Data The data are from ongoing study of maintenance dosing in patients who participated in Aimmune’s Phase 2 clinical trials of AR101. After patients completed the initial portion of the Phase 2 trial — the up-dosing regimen, followed by twelve weeks of low-dose, CODIT maintenance therapy at a daily dose of 300 mg of AR101, and then the subsequent double-blind, placebo-controlled food challenge (DBPCFC) — they were offered the options of staying on low-dose (CODIT) maintenance of 300 mg of AR101 per day or attempting up-dosing to a high-dose maintenance target of 2,000 mg of AR101 per day.All of the 40 patients who completed the initial portion of the Phase 2 trial volunteered to continue on extended maintenance therapy with AR101. Of these, 11 elected to remain on CODIT maintenance therapy of 300 mg of AR101 per day, and 29 chose to attempt up-dosing to high-dose maintenance therapy. The exposure-adjusted, treatment-related, adverse event rate during extended maintenance for patients on CODIT maintenance therapy was one every 574 days. The exposure-adjusted, treatment-related, adverse event rate during extended maintenance for patients on high-dose maintenance therapy was one every 107 days.The 11 patients who elected to remain on CODIT 300 mg maintenance therapy all remained in the study, and the few adverse events they experienced were almost exclusively mild, with only one categorized as moderate. No patients developed new-onset persistent gastrointestinal symptoms and there were no treatment-related serious adverse events (SAEs) during extended maintenance.