Each study participant will be assigned a study identification number. A CRF, containing the participant’s identification number and necessary baseline data, will be completed in paper form. All data will be checked for completeness, entered, and stored in a password-protected electronic database. All original copies of CRFs and all study data in paper form will be stored in a locker within the study site, available for the involved researchers only. Each CRF must be completed, checked for completeness of data, and signed by a researcher. Only the research team and person responsible for statistical analysis of the data will have access to the full trial dataset (blinded of any identifying participant).

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