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Adverse Reactions/Side Effects The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions (5.1)] Malignancies [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4)] Neurologic Reactions [see Warnings and Precautions (5.5)] Hematological Reactions [see Warnings and Precautions (5.6)] Heart Failure [see Warnings and Precautions (5.8)] Autoimmunity [see Warnings and Precautions (5.9)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice

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This national collaborative study is supported by NIH Grant U10AA008401 from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA)