Records of your participation in this study will be held confidential except when sharing the information is required by law or as described in this informational section. The study doctor and staff, the Sponsor or people working on behalf of the Sponsor, and under certain circumstances, the FDA and the Institutional Review Board (IRB), will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified. 

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. 

To make sure that the health information collected in this study is accurate, it will need to be checked from time to time against your medical records. Some people may need to see these records in order to monitor the research and verify the accuracy of the study data, including: A limited number of representatives from the study Sponsor (namely its monitors and auditors); The Institutional Review Board (IRB), Advarra IRB (an independent ethics committee that reviews the ethical aspects of this study to help protect the rights and welfare of study participants); Government regulatory authorities including Health Canada, the FDA, and other foreign regulatory agencies. Your study records including confidential information about you collected during the study will be kept at a secure location. Electronic information will be kept on a secure server. While every effort will be made to protect the privacy of your information, absolute confidentiality cannot be guaranteed. This does not limit the duty of the researchers and others to protect your privacy. 

There are reasons why information about you may be used or seen by the researchers or others during or after this study. Examples include: Clinic, government officials, study sponsors or funders, auditors, and/or the Institutional Review Board (IRB) may need the information to make sure that the study is done in a safe and proper manner. Federal or State law may require the study team to give information to government agencies. For example, to prevent harm to you or others, or for public health reasons. 

‍We will keep the information we collect about you during the research [for future research projects/for study record keeping] Your name and other information that can directly identify you will be stored securely and separately from the research information we collected from you. The researchers may contact you again as part of this project. The results of this study could be published in an article or presentation, but will not include any information that would let others know who you are. 

‍We may use or share your research information for future research studies. If we share your information with other researchers it will be de-identified, which means that it will not contain your name or other information that can directly identify you. This research may be similar to this study or completely different. We will not ask for your additional informed consent for these studies.