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Describe any foreseeable risks to subjects presented by the procedures described above in the Data Collection
section, including any physical, psychological, social, economic, legal, or confidentiality risks. Include your
assessment of the liklihood, magnitude, and repercussions of each risk presented.
For each possible risk presented, provide the measures and precautions you will take to minimize such risks or
to respond to any adverse events, should they occur. What are the possible worst-case scenarios, and how do
you plan to deal with them? How will any adverse effects on subjects be handled or remedied?
CONFLICT OF INTEREST
Do any of the participating study investigators or other key personnel (or their immediate family/significant
other) have a financial or intellectual interest in, or are receiving compensation from, the sponsor or the drugs,
devices or technologies used in this research? If yes, explain the conflict and any mitigating measures.
Do you have or anticipate (within the year) any financial relationships (e.g., consulting, speaking, advisory
boards, patents, equity, options) that could be perceived to overlap or present a conflict of interest with the
current proposal? If yes, describe the overlap.