Provenance Record

Excellent science/medicine News article. Clinical trial data is presented precisely with confidence intervals and p-values. Clear sections for trial findings, dosing, safety, and regulatory context. 727 words within News range.

4 of 5 sources readable. source-0.html.gz (Shionogi global press release — confirms June 1 FDA approval, Nathan McCutcheon quote verbatim, 67% risk reduction, 15.1% vs 15.5% adverse events, headache/diarrhea/cough, no dysgeusia, SCORPIO-PEP). source-1.html.gz (PharmExec — confirms five-day dosing regimen, post-exposure indication only, not for treatment). source-2.html.gz (Shionogi US NEJM announcement, dated May 13 2026 — confirms all trial statistics: 2,387 participants, 2,041 primary analysis, 2.9% vs 9.0% (RR 0.33, CI 0.22-0.49, p<0.0001), high-risk subgroup 2.4% vs 9.9% (RR 0.24, CI 0.12-0.49)). source-3.html.gz (OneDayMD — confirms 3CL/Mpro protease target, no ritonavir needed, SCORPIO-PEP published May 13 2026, fewer drug interactions vs Paxlovid). source-4 (NEJM — HTTP 403 paywall as expected; all cited trial statistics verified from Shionogi's official press releases which constitute the primary source documents). Dosing: PharmExec confirms '375mg loading dose day 1, then 125mg daily days 2-5' — consistent with article's description.

All clinical trial statistics verified verbatim from primary sources: 2,387 enrolled, 2,041 primary analysis, 2.9% vs 9.0% event rate, RR 0.33 (95% CI 0.22-0.49), 76% high-risk subgroup reduction (RR 0.24, CI 0.12-0.49). Nathan McCutcheon quote confirmed verbatim. Japan regulatory history (emergency Nov 2022, full March 2024, PEP approval March 23 2026) noted in article. 'Two weeks ahead of scheduled deadline' claim: source-2 mentions 'PDUFA action date of June 16, 2026', consistent with claim.

High-quality medical News article with all clinical trial data verified from Shionogi official press releases. NEJM paywall is expected — does not affect verifiability since Shionogi published the complete trial data in their own press releases. Approved.