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      "text": "HARMONY 1 and the other pivotal trials allowed concomitant use of a wide range of medications for narcolepsy, cataplexy, and excessive daytime sleepiness, creating a confounding factor that renders the trials flawed and useless.",
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      "text": "HARMONY 1 and the other pivotal trials allowed concomitant use of a wide range of medications for narcolepsy, cataplexy, and excessive daytime sleepiness, creating a confounding factor that renders the trials flawed and useless.",
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      "text": "The trial paper states that 13 out of 31 pitolisant patients continued to use anti-cataplectic drugs at “stable dosage,” yet the trial had no ability to monitor adherence, time of day, or sequence of medications. A table in the FDA review shows the hodgepodge of confounding medications taken during the trial across all 3 arms – for example, 23% of pitolisant patients remained on anti-depressants vs. only 13% in the placebo group. Shockingly, 10% of pitolisant patients vs. none in the other arms took “other antihistamines,” which is particularly confounding as pitolisant targets a histamine receptor.",
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      "text": "The protocol stated that patients could remain on anti-cataplectic drugs like sodium oxybate or antidepressants. However, anti-cataplectic drugs are also used to treat narcolepsy symptoms like EDS, making any distinction between narcolepsy and cataplexy drugs irrelevant – and 81% of patients in the pitolisant arm (25/31) had a history of cataplexy.",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; : https://pubmed.ncbi.nlm.nih.gov/24107292",
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      "text": "Table 11: Concomitant Medications - HARMONY I (P07-03)",
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      "text": "FDA CDER Clinical Review for pitolisant",
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