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Article History

Received: 17 October 2017

Accepted: 9 November 2018

First Online: 13 December 2018

Ethics approval and consent to participate

: This study has been approved for human subject research by the Stanford University IRB (reference number 22436) and undergoes routine review and resubmissions to the appropriate parties. This trial is registered with (NCT02503475) and is supported by the NCCIH (P01 AT006651). All patients must sign the written informed consent form, and the Health Insurance Portability and Accountability Act that is read to them by a trained research coordinator prior to being enrolled into the study. Patients are also given adequate time to decide if they wish to proceed with the trial or pursue other treatment options. Any data, specimens, forms, reports, video recordings, and other records that leave the site will be identified only with a participant identification number (participant ID (PID)) to maintain confidentiality. All records will be kept in a locked file cabinet. All computer entry and networking programs will be done using PIDs only, where possible. All computers are password-protected and encrypted, in compliance with Stanford University’s policies. Information will not be released without written permission of the participant, except as necessary for monitoring by the IRB, the Food and Drug Administration (FDA), the NCCIH, and the Office for Human Research Protections (OHRP).

: Not applicable.

: The authors declare that they have no competing interests.

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