DATA SHARING STATEMENT
Clinical trial data can be requested by qualified researchers for use in rigorous, independent scientific research as long as the trials are not part of an ongoing or planned regulatory submission. Sharing of data is subject to protection of patient privacy and respect for the patient's informed consent. The data will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For approved requests, the data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, contact 