Review the following questions and select the best option by answering either "Yes" or "No" as it applies to your new study submission. Your selections on each proceeding page will help identify the most likely level of review.

Do your research procedures include any of the following:

• Sedation or general anesthesia
• Use of x-rays or microwaves
• Use of a device(s) that is not cleared or approved for marketing
• Use of a cleared device(s) to support new indications
• Evaluation of the safety and effectiveness of a medical device
• Maximal or vigorous exercise testing

• Select "Yes"
• Select "No"

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