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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2025-08-15 00:00:00",
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  "notes": "The slide uses red boxes to highlight specific text in the protocol that contradicts the lack of reporting in the final study.",
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      "text": "We are troubled that Soleno assessed electrocardiogram (ECG) results during the P3 study but the paper buries the results with no mention of ECG - which would capture abnormalities consistent with Vykat-induced heart strain and pulmonary hypertension, hypoxia-related changes, fluid overload, electrolyte-related changes, and hERG/QT elongation.",
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      "text": "We are troubled that Soleno assessed electrocardiogram (ECG) results during the P3 study but the paper buries the results with no mention of ECG - which would capture abnormalities consistent with Vykat-induced heart strain and pulmonary hypertension, hypoxia-related changes, fluid overload, electrolyte-related changes, and hERG/QT elongation. The heavily-redacted Study Protocol and Statistical Analysis plan states that ECG’s were conducted at visit 1 for baseline, visit 6, and visit 7 at completion – “a trained cardiologist at the study site will review the ECG output and provide an assessment of the intervals, segments, abnormalities of T-wave or U-wave morphology”; “descriptive statistics for heart rate, RR interval, PR interval, QRS interval, QT interval, and QT interval corrected with Fridericia’s (QTcF) formula and the change from baseline to each postbaseline visit will be presented.”",
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      "text": "a trained cardiologist at the study site will review the ECG output and provide an assessment of the intervals, segments, abnormalities of T-wave or U-wave morphology — Study Protocol and Statistical Analysis Plan",
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      "text": "Source: https://clinicaltrials.gov/study/NCT03440814; https://cdn.clinicaltrials.gov/large-docs/14/NCT03440814/Prot_SAP_001.pdf",
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      "text": "Phase 3 Study Protocol and Statistical Analysis Plan – ECG sections",
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