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We have represented several of the relevant baseline differences between device arms in the two trials as displayed in Table 6

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Therefore, increased ROS/RNS levels induced by several clinical conditions may play a deleterious effect on different biomolecules (e.g., lipids, proteins and nucleic acids), organelles and antioxidant defenses, leading to exacerbate nitro-oxidative stress, mitochondrial dysfunction, glial activation and inflammatory response

The population also had a high prevalence of overweight (39%), obesity (40%) and physical inactivity