Funding for this research was provided by:
Neuros Medical, Inc.
Article History
Received: 21 December 2023
Accepted: 3 May 2024
First Online: 13 May 2024
Declarations
:
: Prior to receiving any pre-study assessments that would not have been performed as part of standard of care, all subjects voluntarily signed an Informed Consent Form (ICF). Informed consent was obtained in accordance with US FDA regulation 21 CFR Part 50 and local applicable laws. Prior to study initiation, consent forms were reviewed and approved by the Institutional Review Board (IRB). No subject was treated until an ICF, written in a language understandable to the subject, had been signed by the patient and obtained. Additional participation and eligibility criteria is available on clinicaltrials.gov (Identifier NCT 02221934).
: The authors declare that they have no competing interests.