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12 CLINICAL PHARMACOLOGY CLINICAL PHARMACOLOGY SECTION 13 NONCLINICAL TOXICOLOGY NONCLINICAL TOXICOLOGY SECTION 14 CLINICAL STUDIES CLINICAL STUDIES SECTION 16 HOW SUPPLIED/STORAGE AND HANDLING HOW SUPPLIED SECTION 17 PATIENT COUNSELING INFORMATION INFORMATION FOR PATIENTS SECTION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)