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Objective We sought to evaluate long-term relapse rates following lidose-isotretinoin taken without food in patients with severe recalcitrant acne. Design In this single-arm, open-label study, 197 patients received twice-daily lidose-isotretinoin without food for up to 20 weeks. Patients with a 75-percent or higher adherence rate with the protocol-designated dosage and end-of-treatment lesion counts were predefined as the per-protocol (PP) population and evaluated in a 104-week post-treatment period (PTP) to determine the proportion of