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The study was approved by an independent ethics committee (rztekammer Nordrhein, Dsseldorf, Germany) and by the local health authorities (Bundesinstitut fr Arzneimittel und Medizinprodukte) and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice

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antibody refers to immunoglobulin molecules and immunologically active portions of immunoglobulin (Ig) molecules, i.e., molecules that contain an antigen binding site that specifically binds (immunoreacts with) an antigen