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A proportion of children had missing data on samples at the one year visit, primarily because the protocol was started after the beginning of the cohort study.
All psychometric analyses were based on data collected at one year (visit 6), with the exception of assessments of responsiveness in the clinical trial that also used data from baseline and other follow-up visits (visits 2, 3 and 10 – baseline, 13 weeks and 2 years respectively).
Aspirates were also taken from the same children at the scheduled one year visit if they lacked lower respiratory tract symptoms or only had fever and upper respiratory tract symptoms.
After one year (visit 4) and two years (visit 8), parameters will be documented in line with Visit 0. Further annual visits after three and four years, respectively, are optional.
Finally, 11 months after starting the study, the patients were given an appointment in order to receive another new counting device, which was read the following month (one year visit: V3), along with self-reported adherence tests, forced spirometry, SGRQ and measurement of the other variables.
Total lean body mass was stable but fat mass increased 38% between the baseline and the one year visit in type II subjects; this is in contrast to a 14% increase in type III subjects (table 6).
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Both intervention and control group infant anthropometric measures were completed on the questionnaires by the PHN at the one-year visit to the child health care clinic.
Exclusion criteria were training on an alternative AAI device between randomization for the Main Study and the one-year visit, and significant psychological distress at the one-year scenario.
At the one-year visit, the patient was pain-free and had regained a satisfactory range of motion, with no restrains in her activities of daily living.
Participants who completed the one-year visit were more likely to have been successful at six weeks (Table S3).
For patient-related outcome assessment, the Short Form-36 (SF-36) [ 21] questionnaire was completed at the one-year visit, prior to the clinical examination.
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