CALIBRATE

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• Premenopausal or surgically sterile patients; patients with severe heart valve disease; patients with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus; patients with an active cancer diagnosis; patients with body weight >130 kg; patients with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea; patients with liver disease regardless of liver function tests (including a history of cirrhosis, chronic active hepatitis, or severe hepatic disease); patients with lactose intolerance; patients with a history of clinically significant drug or alcohol abuse within the past year requiring pharmacological or non-pharmacological treatment; patients with any of the following non-transient abnormalities documented within the past 30 days and confirmed on repeat testing: anaemia, thrombocytopenia, leukopenia, liver disease, or kidney disease: defined as haemoglobin <6 mmol/L, white blood cell count <3.0 × 10⁹/L, platelet count <110 × 10⁹/L, ALT >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal, or eGFR <35 mL/min; male patients planning to impregnate their partner during the study or within 6 months after the last dose; male patients having intercourse with fertile women who are unwilling to use contraception; patients currently using or planning to initiate chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids permitted); patients currently taking colchicine for other indications (e.g., familial Mediterranean fever or gout), with no wash-out required for those who discontinued colchicine prior to enrolment; patients with a history of allergic reaction or significant sensitivity to colchicine; patients with unstable angina pectoris; patients receiving potent CYP3A4 and/or P-gp inhibitors (including amiodarone, amprenavir, atazanavir, clarithromycin, diltiazem, erythromycin, telithromycin, azithromycin, fluvoxamine, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, saquinavir, nelfinavir, ritonavir, verapamil, voriconazole, pyridamole, roxithromycin, ciclosporin) or with excessive grapefruit consumption; and any patient considered by the investigator, for any reason, to be an unsuitable candidate for the study.