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No other disclosures were reported.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"<b>Declarations<\/b>"}},{"value":"The trial was conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, the principles of the Declaration of Helsinki, and country-specific regulatory requirements. The protocol was approved by the relevant Institutional Review Board\/Independent Ethics Committee for each study site.","order":2,"name":"Ethics","label":"Ethical approval and consent to participate","group":{"name":"EthicsHeading","label":"<b>Declarations<\/b>"}}],"article-number":"210"}}