component	aspects
The hypothesis	Biologic rationale, meta-analysis
The cohort	Demographics, background treatments
Trial design and monitoring	Appropriate design, independence
Primary and subsidiary end points	Relevance, plausibility
Analysis	Intention to treat, on treatment
Net benefit	Absolute benefit, safety
Affordability	Cost–benefit considerations
Intermediate outcomes	Validity as “surrogate” measures
Subgroup analyses	Whether prespecified