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(2.4) Dosage Forms and Strengths Nasal spray: 500 mcg cyanocobalamin/0.1 mL (per actuation) (3) Contraindications Hypersensitivity to cobalt, vitamin B12 or any excipients (4) Warnings and Precautions Severe Optic Atrophy in Patients with Lebers Disease:Patients with early Lebers disease who were treated with vitamin B12 suffered severe and swift optic atrophy

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Multiple dose levels (1, 4, 8, 12 mg) were tested in Phase 2, with the Phase 3 dose selection to be refined based on efficacy-tolerability balance

Matrix stiffening promotes a tumor vasculature phenotype