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      "text": "WCR during the 4-week stable dosing period was assessed by a mixed model featuring Poisson regression, with treatment as a fixed factor, adjusted for WCR, treatment centre as a random factor, and exposure time as offset variables.",
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      "text": "concomitant use of medications by 41% of pitolisant patients... flexible dosing schedule... statistical tricks such as a geometric mean... a \"centre effect\" adjustment... omission of virtually all data on the ESS endpoint",
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      "text": "WCR/placebo WCR between basal and final periods; the 1-month stable medication period is considered for final outcome assessment; and a centre effect, suggested by a previous study is taken into account.",
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      "text": "The Applicant analyzed the effect of the 20 mg dose compared to placebo and the 40 mg dose compared to placebo in the stable dose period. The relative risk of cataplexy events in the 20 mg dosing group was 0.392 (95% CI [0.270, 0.571]; p < 0.0001) and 0.623 in the 40 mg dosing group (95% CI [0.510, 0.761]; p < 0.0001).",
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      "text": "The Applicant analyzed the effect of the 20 mg dose compared to placebo and the 40 mg dose compared to placebo in the stable dose period. The relative risk of cataplexy events in the 20 mg dosing group was 0.392 (95% CI [0.270, 0.571]; p < 0.0001) and 0.623 in the 40 mg dosing group (95% CI [0.510, 0.761]; p < 0.0001). — FDA Review",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; https://pubmed.ncbi.nlm.nih.gov/28129985/",
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      "text": "Other red flags in the CTP trial were the same as HARMONY 1 and 1-bis",
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