Point-of-care photomicroscopy of urine.

n engl j med 364;19 nejm.org may 12, 2011 1880 the steering committee of an imbalance in cancers. They contacted the DSMBs of IMPROVE-IT and SHARP. Merck was not informed of the imbalance. In July 2008, Merck first became aware of the imbalance after database lock and unblinding and provided that information to the SHARP and IMPROVE-IT steering committees, informing them of the need to notify regulators and publicly disclose such information. The clinical trial chairs arranged a metaanalysis of the data, independent of Merck, and reported the findings directly to regulators. The Journal published the analysis. Merck had no input into and did not see the manuscript until after it was accepted for publication. The DSMBs acted independently. We reject any suggestion to the contrary.