Table 2. Revised STAIR Recommendations.

After STAIR XI all prior recommendations were revised, consolidated and updated. Revised STAIR recommendations are separated for two experimental purposes. A. Candidate Treatment Qualification, which means early research and development of a novel, putative treatment. B. Preclinical Assessment and Validation, which means demonstrating efficacy in stroke models that have a likelihood of predicting success in subsequent patient clinical trials.

A. Candidate Treatment Qualification
Dose Response	Treatment effect varies with changes in dose
Time Window	Treatment remains effective when administered after clinically relevant delay times
Histological and behavioral outcomes	Beneficial effects can be demonstrated using measures of behavior and tissue damage
Target Engagement	Candidate treatment reaches presumed target and causes expected physiological effects
Barrier Penetration	Candidate treatment enters brain
B. Preclinical Assessment and validation
Sample Size	Sample size should be pre-specified based on known or assumed standard deviation and predicted effect size
Inclusion/Exclusion criteria	Effective MCA occlusion is confirmed using laser Doppler or other flowmetry or symptom severity
Randomization	Animals are randomized prior to initiation of any study procedures
Allocation concealment	Surgeon performing stroke remains unaware of treatment assignment
Reporting on excluded animals	Subjects lost at each experimental step after randomization are summarized
Blinded assessment of outcome	Investigators remain unaware of treatment assignment during all assessments
Age	Consider effects of age on outcome
Sex	Males and females should be assessed. Dose response differences between sexes should be determined
Co-morbidities	Ideal models of stroke co-morbid conditions (e.g., diabetes or hypertension) need to be refined
Multiple laboratories	Concordant effects should be demonstrated across multiple laboratories using similar methods.
Gyrencephalic species	Demonstration of efficacy in gyrencephalic species, particularly non-human primates may contribute to predicting clinical efficacy
Circadian Effects	Preclinical testing of therapies during the awake phase of rodent models should be considered.
Reporting of investigator or institutional conflicts of interest	Investigator and institution conflicts are reported and managed

NB: STAIR recommendations are not guidelines or protocols, but rather consensus suggestions from an expert panel for investigators to consider.