Study Oversight
The executive committee designed and oversaw
the conduct of the trial and data analysis in collaboration
collaboration
with the sponsor, Novartis. The trial
was reviewed by an independent data and safety
monitoring committee. Data were collected, managed,
and analyzed by the sponsor according to a
predefined statistical analysis plan, and the analyses
were replicated by an independent academic
statistician. The first draft of the manuscript was
prepared by the first two authors, who had unrestricted
access to the data, and was reviewed and
edited by all the authors. All the authors made
the decision to submit the manuscript for publication
and assume responsibility for the accuracy
and completeness of the analyses.