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Finally, the scope and design of the FIH trial and subsequent studies (e.g., treatment duration) must be considered in order to design appropriate pivotal preclinical studies that will both enable the planned clinical studies and adequately inform of potential safety risks for the intended patient population or healthy volunteers

1997 Jan 29;68(2):131-8

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The sample sizes were determined based on preliminary experiments and previous studies using similar models

Activated microglia produce ROS and pro-inflammatory cytokines, contributing to the oxidative and inflammatory environment in the PD brain

But, you know, you can't onboard 20,000 people overnight and then people are like, oh, you guys suck