Author Contributions: Dr Joensuu had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Joensuu, Eriksson, Hall, Pink, Bono, Leinonen, Alvegård, Reichardt.
Acquisition of data: Joensuu, Eriksson, Hall, Hartmann, Pink, Schütte, Ramadori, Hohenberger, Duyster, Al-Batranm, Schlemmer, Bauer, Sarlomo-Rikala, Nilsson, Sihto, Monge, Bono, Kallio, Reichardt.
Analysis and interpretation of data: Joensuu, Eriksson, Hall, Schütte, Ramadori, Schlemmer, Wardelmann, Sihto, Monge, Bono, Leinonen, Reichardt.
Drafting of the manuscript: Joensuu, Eriksson, Hall, Sarlomo-Rikala, Vehtari, Reichardt.
Critical revision of the manuscript for important intellectual content: Joensuu, Eriksson, Hall, Hartmann, Pink, Schütte, Ramadori, Hohenberger, Duyster, Al-Batran, Schlemmer, Bauer, Wardelmann, Sarlomo-Rikala, Nilsson, Sihto, Monge, Bono, Kallio, Vehtari, Leinonen, Alvegård, Reichardt.
Statistical analysis: Joensuu, Vehtari, Leinonen.
Obtained funding: Joensuu, Hall, Ramadori, Reichardt.
Administrative, technical, or material support: Joensuu, Eriksson, Hall, Hartmann, Schütte, Hohenberger, Duyster, Al-Batran, Schlemmer, Sarlomo-Rikala, Nilsson, Sihto, Monge, Alvegård, Reichardt.
Study supervision: Joensuu, Eriksson, Schütte, Hohenberger, Schlemmer, Bauer, Nilsson, Reichardt.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Eriksson, Schütte, Ramadori, Hohenberger, Duyster, Schlemmer, Bauer, Wardelmann, Bono, and Reichardt report having received honoraria from Novartis for speaking, consulting, or participating in advisory board meetings. The research institutes of Drs Joensuu, Wardelmann, and Reichardt have received payment for consultancy, board membership, or lectures from Novartis. Drs Ramadori, Al-Batran, Wardelmann, and Reichardt have received research support from Novartis. Drs Schütte, Duyster, Bauer, and Reichardt have received support for travel to meetings for the study or other purposes from Novartis. Drs Hohenberger, Duyster, and Wardelmann have received support for educational presentations or courses from Novartis, Dr Eriksson for writing conference reports, and Dr Joensuu and Wardelmann for serving on a data safety monitoring board. No other conflicts of interest were reported.
Funding/Support: This study was sponsored by the Scandinavian Sarcoma Group and funded by Novartis Oncology; Academy of Finland (grants 218068 and 131449); Cancer Society of Finland; Sigrid Juselius Foundation, Finland; and Helsinki University Research Funds (grant TYH7206). Novartis Oncology provided the study drug.
Role of the Sponsors: The study was designed by the authors; Novartis Oncology reviewed the study protocol. The funding organizations had no role in the conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Independent Statistical Analysis: Since Novartis supported statistical analysis carried out by the company of Mr Leinonen, all statistical analyses were reviewed independently by an academically affiliated statistician (Mr Vehtari), who received no financial or other support for his work.
Online-Only Material: The study protocol and statistical analysis plan are available at http://www.hus.fi/huchtrialprotocols.
Additional Contributions: We thank the Scandinavian Sarcoma Group (SSG) secretariat at Oncological Centre, Skåne University Hospital, Lund University, Sweden (Ms Jeanette Ceberg, Ms Elisabeth Johansson, Ms Eva-Mari Olofsson, and Ms Maria Rejmyr-Davis), for skillful assistance. These individuals were employed by the SSG and received no compensation from the study funding organizations. We are indebted to the study participants and the study nurses, data managers, and monitors.