Ethics approval statement:
The authors declare that this manuscript adheres to the journal’s
Declaration of Transparency and Scientific Rigor, that the studies from
which data was collected and analyzed were approved by the ethics
committees of the participating investigational sites, and that the
studies conform to Declaration of Helsinki; US Federal Policy for the
Protection of Human Subjects; MHRA Good Clinical Practice for Clinical
Trials; or European Medicines Agency Guidelines for Good Clinical
Practice.