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Disclaimer: This document is the work product of the N=1 Collaborative (the “N1C”), and is offered as an example only. The N1C is not providing legal or regulatory advice for N=1 trials. This document should not be construed as legal or regulatory advice for any particular purpose. Any future use of this document should be tailored to specific trials based, for example, on pre-clinical data ASO chemistry and mechanism, patient disease, and evolving body of knowledge, and where appropriate, should separately be subjected to legal review.