Study concept and design: D’Amico, Kantoff.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: D’Amico, Chen.
Critical revision of the manuscript for important intellectual content: D’Amico, Chen, Renshaw, Loffredo.
Statistical analysis: Chen.
Administrative, technical, or material support: D’Amico, Loffredo.
Study supervision: D’Amico, Kantoff.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Trial Registration: clinicaltrials.gov Identifier: NCT00116220