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Post-market surveillance studies follow the principles of Good Epidemiological Practice and the study protocol is reviewed and approved by an Independent Ethics Committee

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doi:10.15585/mmwr.mm6514a1

The mean FTND score remained very low at the follow-up at two moths (mean=0.39, SD=0.87), and although a slight increase was observed at five months (mean=1.03, SD=2.04), it remained substantially below baseline levels

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