Sample requirements — Unrestricted
Treatment (optional)
Applies to the case arm. For treatment vs control, the comparator needs the opposite exposure state for the same agent and collection window. Other comparisons keep their own normal or healthy comparator requirements.
Missing metadata never proves absence of treatment. Exact results require an eligible subset and reported independent subjects in both arms.
“No exposure” applies only to the chosen agent, target and time window. Before a new agent does not mean no prior therapy. Broad treatment history needs separate explicit evidence and may be unavailable.
The requirement applies to the case arm; the comparator keeps its own requirements.