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© 2020 The Authors. Journal of Cellular and Molecular Medicine published by Foundation for Cellular and Molecular Medicine and John Wiley Sons Ltd.OBJECTIVE Assess safety and efficacy of lenabasum in diffuse cutaneous systemic sclerosis (dcSSc). METHODS A double-blind, randomized, placebo-controlled Phase 2 study was conducted at nine SSc clinics in the USA. Adults with dcSSc ≤ 6 years duration on stable standard-of-care treatment received lenabasum (N = 27) or placebo (N = 15). Lenabasum doses were 5 mg once daily (QD), 20 mg QD,