Data availability
Raw data related to safety and feasibility, the primary endpoints of the study, can be shared upon request and review by Cleveland Clinic and the study sponsors. Secondary endpoint data and PET imaging data, analyzed or raw, may also be shared. Depending on the data that are requested, we will need to consult with the IRB and sponsors before sharing. Cleveland Clinic has regulations related to data sharing, in particular data that could be used as identifiers. The investigators and the IRB will need to verify that data sharing would be acceptable and within policy for patient protection and within the limits of the informed consent provided by participants when enrolling in the study. The investigators will also have to consult the sponsors before data sharing. Patient-related information not included in this report was collected as part of a clinical trial and may be subject to patient confidentiality.Given the restricted study population and small sample size, even though any dataset will be stripped of identifiers before release for sharing, we believe that there remains the possibility of deductive disclosure of participants by unique combinations of characteristics. Therefore, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for a commitment to: (1) using the data only for research purposes and not to identify any individual participant; (2) securing the data using appropriate computer technology; and (3) destroying or returning the data after analyses are completed.Requests for data can be sent to A.G.M. All requests will be answered within 4 weeks. We anticipate that data will be shared, if there are no risks or low risks to the participants.