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Abstract
Background
New guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies.
Main body
We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment.
Conclusions
We highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.
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Details
1 SUNY Upstate Medical University, New York, USA (GRID:grid.411023.5) (ISNI:0000 0000 9159 4457)
2 The New England Institute for Neurology and Headache, Stamford, USA (GRID:grid.479692.7)
3 Harvard Medical School, Boston, USA (GRID:grid.38142.3c) (ISNI:000000041936754X); Mass General Brigham Health, Department of Neurology, Foxboro, USA (GRID:grid.32224.35) (ISNI:0000 0004 0386 9924); Atrius Health, Department of Neurology, Quincy, USA (GRID:grid.32224.35)
4 UTHealth Houston, Department of Neurosurgery, Houston, USA (GRID:grid.32224.35)