Since publication of the above manuscript, the authors have become aware of two areas that require adjustment.
In the Safety section of the manuscript (Results, Safety, fourth sentence), patients who prematurely discontinued study treatment due to adverse events but who remained in the study and continued to be seen and assessed by the investigator during subsequent scheduled study visits, were incorrectly described as having discontinued the study. This sentence should have been presented as follows: “Although a comparable number of patients discontinued study treatment due to AEs (27 budesonide/formoterol patients versus 28 salmeterol/fluticasone patients), a greater number of salmeterol/fluticasone patients withdrew owing to asthma versus budesonide/formoterol patients (11 versus three patients, respectively).”
In addition to the above, the following should have been presented as the last paragraph in the Study design section (Methods, Study design):
“Patients discontinuing study treatment prematurely were asked to complete their notebook for the remainder of the 12-month study period and to attend the remaining scheduled study visits. Patients who agreed to this were regarded as having discontinued the study treatment but not as having discontinued the study. At discontinuation of study treatment, patients were assessed by the investigator, asked about the reason for discontinuation and any adverse events were followed up as necessary. Adverse event data collected for patients discontinuing study treatment were limited to serious adverse events. Patients discontinuing the study permanently who did not agree to completing the notebook and assessments further to discontinuing study treatment, were recorded as having discontinued the study.”
The authors apologise for these omissions.
- ©ERS 2011