 16. Unable or unwilling to use reliable methods of contraception, as outlined in the Mycophenolate REMS e.g., Risk Evaluation and Mitigation Strategy, from four weeks prior to randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential. Reference: Mycophenolate REMS, Program Resources and Educational Materials, Information for Patients, What are my birth control options? Access the link at: 