Text and Data Mining valid from 2019-06-04
Received: 31 July 2018
Accepted: 8 May 2019
First Online: 4 June 2019
Ethics approval and consent to participate
: Each participant provided written informed consent to participate in the study. All studies were conducted in accordance with the Declaration of Helsinki and approved by independent institutional review boards before initiation (Study 1: US Institutional Review Board, Inc., Miami, FL, USA, Reference number: U.S.IRB2016SRG/01; Study 2: Veritas IRB, Montreal, Canada, Reference number: 16045–16-02:5011-03-2016; Study 3: Veritas IRB, Montreal, Canada Reference number: 16087–12:05:1921-12-2016). These studies are registered atExternalRef removed: Study 1: NCT02832375; Study 2: NCT02731833; Study 3: NCT02923895.
: N/A: no details, images, or videos relating to an individual person are included in the manuscript.
: Jonathan Creeth, Farzana Sufi and Paola Gomez Pereira are employees of GSK Consumer Healthcare, who funded the study and developed the Test product that was the subject of this manuscript.Silverstone Research, of whom John Gallob is an employee, All Sum Clinical Research, of whom Chhaju Goyal and Jimmy Qaqish are employees, and Syneos Health, of whom Chandrashekhar Budhawant is was an employee at the time of the study, have all received funding from GSK Consumer Healthcare.
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