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All data in this study will be collected by nurse assessors with experience in aged care.
All data for this study will be collected through web-based questionnaires.
Data generated by this study will be collected in the field by one member of the research team (RH).
Electronic case report forms (eCRFs) must be completed for each patient screened/enrolled and the data for this study will be collected with an electronic data capture application.
All of the data for this study will be collected according to protocol and recorded on paper forms developed to insure the consistency and accuracy of collection.
Demographic and other relevant data that describe the population contributing to this study will be collected at baseline using the questionnaires presented in Table 1.
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The data of the study will be collected on a data collection sheet, a one-sided form sheet which the participating investigator will have identified with the number of randomization indicated on this sheet, on the symptom sheet given to the patient and on the medication bottle given to the patient.
Reasons for unblinding, before the termination of the study, will be collected.
Clinical, analytical and exploratory data needed for the study will be collected by the investigator.
The socio-demographic variables, together with those on the smoking habits of the participants that decline to participate in the study, will be collected in a separate report.
Information relating to the feasibility and logistics of the study will be collected from Group A's subjects at the end of the eight-week treatment program.
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