Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.

ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).

The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.

The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.

The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.

The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.

The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.

High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).

The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.

At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.

The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.

The maximum plasma concentration (Cmax) is the highest level of drug in plasma.

Time (in relation to dosing) at which the maximum plasma concentration is observed.

The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.