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. 2023 Jun 26;9(3):00633-2022. doi: 10.1183/23120541.00633-2022

TABLE 2.

Key inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
Male or female, aged ≥18 years# and ≤85 years at screening AST and/or ALT >3× ULN at Visit 1
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice and local legislation Estimated glomerular filtration rate according to CKD-EPI formula <30 mL·min−1 at Visit 1
Women of childbearing potential adhering to contraception requirements Absolute blood neutrophil count <1000/mm3 at Visit 1
Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by CT scan Acute SARS-CoV-2 infection
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: 1) at least two exacerbations, or 2) one exacerbation and an SGRQ symptoms score of >40 at Screening Visit 1 Current smokers, or stopped smoking only within 3 months of screening, or not willing to maintain non-smoking status for the duration of the study
Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous sputum sample at Screening Visit 1 Current diagnosis of cystic fibrosis, hypogammaglobulinaemia, common variable immunodeficiency, α1-antitrypsin deficiency, or allergic bronchopulmonary aspergillosis requiring treatment
Any acute infections (including respiratory infections)
Any mycobacterial infections, including pulmonary non-tuberculous mycobacterial disease, currently being treated
Severe periodontal disease (to be evaluated by a periodontist or dentist) or palmar keratosis
Any recent change in dose or regimen of maintenance bronchiectasis treatment
Any medical condition that could interfere with participation or conduct of the study

AST: aspartate aminotransferase; ALT: alanine aminotransferase; ULN: upper limit of normal; CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; CT: computed tomography; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2; SGRQ: St George's Respiratory Questionnaire. #: ≥ 19 years in Republic of Korea; : if allowed according to regulatory requirements.