Morris, Paul http://orcid.org/0000-0001-7427-4213
McDermott, Simon
Chapman, Fiona
Verron, Thomas
Cahours, Xavier
Stevenson, Matthew
Thompson, Joseph
Chaudhary, Nveed
O’Connell, Grant
Article History
Received: 7 April 2021
Accepted: 21 July 2021
First Online: 26 August 2021
Declarations
:
: This work was funded by Fontem US LLC, a subsidiary of Imperial Brands PLC, and manufacturers of the <i>my</i>blu<sup>™</sup> products used in this study. This work was performed by Imperial Brands PLC on behalf of Fontem US LLC as a service provider. Work was contracted to Celerion, who conducted the study and analysed the data. At the time of the study and/or writing, PM, SM, FC, TV, XC, MS, JT, NC and GOC were employees of Imperial Brands PLC.
: The study was carried out in accordance with the ethical principles set forth in the Declaration of Helsinki. The study protocol for Study 1 was reviewed and approved by Advarra Institutional Review Board (IRB) (Columbia, MD) and the study protocol for Study 2 was reviewed and approved by IntegReview IRB (Austin, TX). Any subsequent amendments were also approved by the same respective IRBs.
: All subjects provided informed consent. All prospective subjects had the study explained to them by the investigator or their designee and were required to read, sign and date an Institutional Review Board (IRB) approved Informed Consent Form (ICF) prior to completion of screening or other study procedures.