The study was monitored by an independent
data and safety monitoring committee, which
met regularly during the course of the study to
review all safety data in an unblinded manner
and which identified no safety concerns. The
primary efficacy end point has been reached and
is reported here. Because the study is ongoing to
allow for collection of data that are required to
assess several secondary end points, the authors
remain unaware of participant-level data at this
stage of the analysis.