DATA SHARING STATEMENT: Individual participant data will be available that underlie the results reported in this article, after deidentification (text, tables, figures and appendices); beginning nine months and ending 36 months following article publication; and for investigators whose, proposed use of the data has been approved by an independent review committee identified for individual participant data meta-analysis. The study protocol is accessible through


Reference: Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. JAMA 2017; 317: 2491-2.