Consent to collection, storage and use of personal data

This policy describes how Trialbee AB (“Trialbee”), company registration number 556814-3019, address: Södra Tullgatan 3, 211 40 Malmö, Sweden, [email protected], gathers, uses, stores and shares personal data on behalf of the study sponsor, LivaNova USA, Inc. (“LivaNova”), Company registration No. 09451374, 100 Cyberonics Blvd., Houston, TX 77058.

LivaNova is the sponsor of a clinical study which is evaluating the efficacy of VNS Therapy® when administered as an adjunctive treatment in subjects with treatment-resistant depression. As part of the initial eligibility and qualification process for the study, Trialbee may collect and store your personal data/information, on behalf of the study sponsor. The information you provide will be kept confidential and secure in accordance with applicable data protection and privacy laws.

If you are interested in participating in this study, Trialbee will ask you, on behalf of the study sponsor, to provide certain information about yourself to see if you qualify for the study. The information we intend to collect includes: your name, telephone number(s), e-mail address, and answers to questions we ask you for determining eligibility. These answers may include your personal health information, which may include information about your medical and treatment history and insurance.

The information you provide, including your health information, will only be used for the purposes of determining your eligibility for the study. Trialbee may share any information you provide with the study sponsor to evaluate your eligibility, and Trialbee and the study sponsor may contact you to discuss your participation in the study. In addition, your information may be shared with LivaNova’s clinical trial partners who are participating in this study (which are all health care providers within the United States).

Information about you is stored in Trialbee’s system (and may also be stored by the study sponsor or its clinical trial partners) until the clinical study recruitment is completed or until you request that the data is deleted, whichever occurs first.

You can withdraw your consent at any time by contacting Trialbee at [email protected] If you withdraw your consent, the study sponsor and Trialbee will stop using your personal data for such purposes.

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