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Privacy Policy

A federal government rule has been issued to protect the privacy of patients. This rule was issued under a law called the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The law is designed to protect the confidentiality of your personal health information, which includes existing medical records needed for this study and new information created or collected during the study.

The trial participant consent to the use of records for data verification purposes will be obtained prior to the trial. Once the study commences, study data will not include your name, address, social security number, or other information that directly identifies you. Instead, the study team assigns a unique identifier (consisting of your initials and a code number) to your personal information. Study sponsors could have access to your personal information while reviewing the study for overall conduct and accuracy. However your personal information will not be disclosed to any outside authorities without your explicit written permission.

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