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GH was involved in the trial conception and design.
CJM was involved in the trial conception and design.
NT contributed to trial conception and design as well as assisting with manuscript preparation.
SB was involved in the trial conception and design and in trial management.
ES was involved in the trial conception and design and in data collection.
LD was involved in the trial conception and design and in trial management.
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A steering committee will oversee the detail conduct of the trial from conception to termination, interpretation of the results, and final publication of the results.
First, at the time of the trial's conception, both agents had shown activity in the treatment of advanced breast cancer.
Prior to enrollment, potential participants will be advised that they will exit the trial if conception occurs before 3 mo of the biweekly home visits or if they are not among the first half of Stage 1 participants whose conception is confirmed after this first 3 mo period.
Exposed to bivalent HPV vaccine were pregnancies in women initially randomized to bivalent HPV vaccine in the main trial with conception dates either in that trial or in the long term follow-up study, and pregnancies exposed to bivalent HPV vaccine as a result of the crossover.
Appropriate patient selection, clinical trial design, immunologic monitoring, and appropriate endpoints are all essential to the efficiency and success of bringing cancer vaccines from conception to clinical use.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com