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Troisi, G. Scala, and M. Guida have an Italian patent for the diagnostic test described in the manuscript (Patent no. 0001423755\/2016) and have applied for a PCT extension. All the other authors have no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the local ethics committee (IRB n.4\/2013) and a written consent form was signed by each participant.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}],"article-number":"77"}}