The blinded database was held at a
third-party contract clinical research organization,
and queries were issued by both the sponsor
and the staff of the clinical research organization.
The statistician employed by the independent clinical
research organization provided the analysis to
the independent data and safety monitoring committee,
whose members were invited by the sponsor.
After the independent data and safety monitoring
committee recommended unblinding of the
data, analyses of the data were performed by a statistician
employed by the sponsor, and the results
were reviewed by the authors.