While these CSF biomarkers represent the gold standard for the molecular characterization of neurodegenerative diseases, collecting CSF from patients for long-term observation is not feasible due to its invasive nature (Konkov et al., 2022)
Our team monitors each child closely, adjusts the program when needed, and coordinates rehabilitation sessions during the stay
Something along the lines of: "The formulation and efficacy of this material has not be tested or verified by the FDA." Hopefully that would give the potential users pause and provide some future cover when someone invariably has an adverse reaction to the products and sues
The secondary outcomes will be the serum vitamin B12 concentration (pg/ml), adverse events (description, moment of onset and resolution, intensity, cause, steps taken), adherence to treatment (measured at each patient visit via the number of vials used for patients in the oral arm, and the number of injections given in the intramuscular arm), quality of life (measured using the EuroQoL-5D questionnaire), and patient satisfaction and preferences
Treatments should always be conducted under the supervision of a qualified healthcare provider