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The key distinction is that an AE occurs temporally in association with the trial , even if its not caused by the investigational product

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Abbreviations GalN: D-galactosamine GP: Glutathione peroxidase GR: Glutathione reductase GSH: Reduced glutathione GSSG: Oxidized glutathione GCS: -glutamylcysteine synthetase GCS-HS: Catalytic (heavy) subunit of-glutamylcysteine synthetase GCS-LS: Regulatory (light) subunit of-glutamylcysteine synthetase SOD: Superoxide dismutase IL-6: Interleukin-6 STAT3: Signal transducer and activator of transcription 3 TNF-: Tumor necrosis factor- NF-B: Nuclear factor kappa B GOT: Glutamic oxaloacetic transaminase GPT: Glutamic pyruvic transaminase ROS: Reactive oxygen species NOS: Nitric oxide synthase G6PD: Glucose-6-phosphate dehydrogenase 6PGD: 6-phosphogluconate dehyderogenase HMP: Hexose monophosphate pathway References Akerboom TP, Bilzer M, Sies H (1982) The relationship of biliary glutathione disulfide efflux and intracellular glutathione disulfide content in perfused rat liver