{
  "created_utc": "2026-10-13T22:11:27.235732+00:00",
  "status": "Exploratory; written after source inspection and before revision calculations. Not a preregistration.",
  "question": "Does incorporating the publicly reported COVID-OUT day-28 endpoint change the targeted aggregate hospitalization/death audit?",
  "primary": "Add registry day-28 COVID-OUT to previous three day-28 contrasts. Do not also include its day-14 endpoint. Preserve cause-definition distinctions.",
  "analyses": [
    "Recompute previous result as a baseline",
    "Day-28 four-contrast random-effects DL with modified Hartung-Knapp interval and common-effect reference",
    "Leave-one-contrast-out; placebo-controlled only; remove high-dose accidental death; two absent high-dose control outcomes",
    "Replace COVID-OUT day 28 by day 14 as mixed-window sensitivity, without duplication",
    "Enumerate all 550 TOGETHER hospital/death unions with updated primary cohort",
    "COVID-OUT denominator sensitivity conditional on registry endpoint sample being nested within published modified-intention-to-treat cohort of 410/398; no inference of missingness cause",
    "IVERCOR end-of-study hospitalization reported separately; no silently imputed day-28 union",
    "Original PRINCIPLE concurrent versus historical-control diagnostic"
  ],
  "claims_scope": "Reproducible aggregate-data resource; no universal causal efficacy, equivalence, or clinical recommendation."
}