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Article History

Received: 25 November 2019

Accepted: 19 January 2020

First Online: 30 January 2020

Ethics approval and consent to participate

: This trial protocol has been approved by the Institutional Review Board (IRB) of Beth Israel Deaconess Medical Center (Protocol 2018P000530). The approval for the trial protocol at Clinica Eugin in Spain is pending. All participants in the trial will provide written informed consent. Subsequent to initial review and approval, the responsible IRBs will review the protocol at least annually. The principal investigator will make safety and progress reports to the IRBs at least annually and within 3 months of study termination or completion at individual study sites. These reports will include the total number of participants enrolled, adverse events and summaries of each DSMB review of safety and/or efficacy.We will seek formal amendment to the protocol for any modifications which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects. Such amendments will be approved by the IRB prior to implementation. At the discretion of the principal investigator the IRB may be notified of minor administrative changes to the protocol and/or clarifications that have no effect on the way the study is to be conducted.

: Not applicable.

: The authors declare that they have no competing interests.