Acknowledgements: Writing and editing assistance, including preparation of a draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by James A. Shiffer, RPh and Jamie Dermatis, DPM (Write On Time Medical Communications, LLC, NJ).
Conflicts of interest: SCB, AS, LEK, and AA are employees of Stealth BioTherapeutics (Newton, MA).
Funding : The trial was funded by Stealth BioTherapeutics (Newton, MA).
Data availability: The data that support the findings of this study are available from the corresponding author upon reasonable request. Some data may not be made available because of privacy or ethical restrictions.
Clinical trial registration: This Phase 1 study was not preregistered following guidelines in 42 Code of Federal Regulations (CFR) Part 11.