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Response was defined as a ≥50 % reduction from baseline in the number of CH attacks during the randomised period (or during month 2 in the case of 4 late responders).
The long-term data from BEST were collected after the end of the 1-year randomised period.
Pancreatin was well tolerated; there were no serious adverse events, or adverse events leading to discontinuation, during the randomised period.
Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period).
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Patients were studied over 48 weeks, receiving either prucalopride or placebo given once a day for four randomised periods of 12 weeks.
Patients who experience subacute worsening of POEMS syndrome with subacute capillary leak-like symptoms (ie, 5 kg/month of weight gain or pleural effusion increase) or evident deterioration of neuropathy (ie, increase in the total score on the overall neuropathy limitation scale of >2) will promptly be shifted from the randomised comparative period to the long-term safety period.
50, 59 During the 4-week randomised withdrawal period, patients who were re-randomised to placebo after taking linaclotide for 12 weeks reported that the linaclotide-induced improvements in abdominal pain and CSBM frequency diminished to levels similar to those reported by patients in the placebo group over the treatment period.
Results: Although there was no difference in Montgomery Åsberg Depression Rating Scale (MADRS) scores at the end of the randomised treatment period, by the end of the open treatment phase the reduction in MADRS scores was significantly greater in the infusion group than in the tablet group (p=0.015).
The majority of subjects (99%) received 2000 mg metformin throughout the randomised treatment period.
Eleven patients in the rosuvastatin group and 12 in the atorvastatin group discontinued during the randomised treatment period (figure 2).
At completion of the 24-week randomised treatment period, all patients were offered open-label treatment with TCZ 8 mg/kg plus MTX.
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