Threshold values for BUN (from ≥5.7 μmol/L to ≥14.28 mmol/L [≥40 mg/dL]) and serum creatinine (≥89 μmol/L to ≥176.8 μmol/L [≥2 mg/dL]) exclusion criteria were corrected for consistency with the Summary of Product Characteristics (SmPC)/ PI and to avoid unnecessary screening failures. The threshold value for serum creatinine in the treatment discontinuation criteria was corrected. The threshold value for BUN in the discontinuation criteria was deleted as not considered medically relevant. Creatinine clearance as an exclusion criterion was deleted due to the threshold value being updated to cover the detection of potential renal AEs. Audiology testing requirements at baseline and/or at the subsequent visits were updated to be in line with the SmPC and PI. They were at the discretion of the investigator. Audiology assessments were not required from a subset of patients at selected sites, but from all patients who had a medical history of hearing loss or who experience AEs related to hearing loss during the study. The wording for the primary objective was updated to clarify that the cumulative times required to a) set up the delivery device (including preparation of the treatment), b) administer the drug and c) clean the device (including disinfecting the nebulizers where applicable) are being compared between the T-326 Inhaler and the nebulizers. The wordings for the study purpose and for one secondary objective were updated to clarify that the testing of the inhalation devices for microbiological contamination relates to all nebulizers used by the patients, including those for inhaling other medications (e.g. mucolytics). Clarified that semi-quantitative culture data for non-P. aeruginosa pathogens was collected and analyzed for this study. Clarified that re-screening of patients was allowed.