Concept and design: S Ailawadhi, D Romanus, S Shah, K Fraeman, D Saragoussi, R Morris Buus, Lois Lamerato, Ariel Berger. Acquisition of data: D Romanus, K Fraeman, D Saragoussi, R Morris Buus, Lois Lamerato. Analysis and interpretation of data: S Ailawadhi, D Romanus, S Shah, K Fraeman, R Morris Buus, B Nguyen, D Cherepanov, L Lamerato, A Berger. Drafting of the manuscript: S Ailawadhi, D Romanus, S Shah, D Saragoussi, R Morris Buus, B Nguyen, D Cherepanov, A Berger. Critical revision of the paper for important intellectual content: S Ailawadhi, D Romanus, S Shah, D Saragoussi, R Morris Buus, B Nguyen, D Cherepanov, L Lamerato, A Berger. Statistical analysis: S Shah, K Fraeman, A Berger. Provision of study materials or patients: R Morris Buus. Obtaining funding: D Romanus, D Cherepanov, Berger. Administrative, technical, or logistic support: D Romanus, R Morris Buus, D Cherepanov. Supervision: S Ailawadhi, D Romanus, D Cherepanov, L Lamerato, A Berger. Other (initiation, oversight, statistical analysis plan development): D Romanus.