2.6. Study oversight

The NRG Oncology/Gynecologic Oncology Group and GOG designed and conducted this study. The study was approved by the research ethics board at each participating center or by a central institutional review board and all patients provided written informed consent. With reviews by the data and safety monitoring committee, the data were collected, held, and analyzed by the statistical group. The first author (study chair) vouches for the integrity of the data and analyses reported and for the fidelity of the trial to the protocol. Representatives from the sponsors (the Cancer Therapy Evaluation Program of the National Cancer Institute and Pfizer) had no role in the design, accrual, management or analysis of the data. The drafting and content of the manuscript and the decision to publish was undertaken by the first author with input from all the coauthors.