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  "notes": "The slide highlights the ambiguity in the definition of 'cataplexy' used in the study protocol, leading to potential data reliability issues.",
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      "kind": "callout",
      "text": "Foreign trial with 40% of patients in Hungary and Argentina – FDA review",
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      "text": "The primary endpoint of Weekly Rate of Cataplexy was highly subjective and based on a patient-reported diary, rendering the data low-quality and questionable.",
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      "text": "The primary outcome for this study was the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable dosing (weekly cataplexy rate [WCR]). Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion. For each patient, we calculated the final weekly cataplexy rate (WCRf) measured during week 4 of stable dose treatment, and the corresponding baseline rate (WCRb) measured during the 2 weeks preceding randomisation. The cataplexy reduction was measured by the ratio WCRf/b=WCRf/WCRb.",
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      "text": "The primary endpoint of Weekly Rate of Cataplexy was highly subjective and based on a patient-reported diary, rendering the data low-quality and questionable. The definition of cataplexy per the protocol was amorphous and open to extensive patient interpretation, particularly given the inclusion of partial cataplexy: “Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion.” A patient could consider a brief jerk, twitch, blinking, grimace, or an emotional reaction as partial cataplexy, and could easily associate any body sensation as cataplexy during emotional triggers such as laughter, excitement, stress, or anger.",
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      "text": "Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion. — Study Protocol/Pubmed",
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