Portincasa 2017
With advancements in HRW preparation methods, such as water electrolysis (Santos et al., 2017), metal-acid reactions (Xie et al., 2020), and high-pressure dissolution, an increasing number of clinical trials have begun to adopt the consumption of hydrogen-rich water as a means of hydrogen intake for the treatment of neurological disorders
Also tell them about any procedures that use anesthesia
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As FDA states in their guidance document on the Q-Submission program, Early interaction with FDA on planned non-clinical and clinical studies and careful consideration of FDAs feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. While this is not meant to be a general pre-review of your submission, it is there to help you get answers to questions directly from FDAwhich will contribute to a smooth submission and, hopefully, approval