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Each patient underwent a high-resolution T1-weighted volume MRI scan both at entry in the study and 18 months later.
The observation period included the time of patient's entry in the study and collection of data at baseline and a second visit after 6 months.
Pretreatment with an antidepressant and/or mood stabilizer medication had to be stable for at least 4 weeks prior to entry in the study and remain unchanged throughout.
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This trial comprised participants who had been screened for entry into the study and in whom HF status was ascertained.
The use of audit of treatment received versus NICE Guidelines before entry into the study and in the two year follow up period will aid the interpretation of the study by benchmarking care received against national guidelines [ 8, 20].
Five of those patients were in a coma upon entry into the study, and the other two had cognitive impairment and generalized weakness.
(These questionnaires also ascertain changes in exposure variables since entry into the study and extend the range of questions about exposures (e.g., when new scientific questions arise), and the mailing can be used to obtain repeat blood samples).
CTX-II was also correlated with ESR, ICTP, and the Larsen score at entry into the study, and the change in CTX-II at the end of 2 years was associated with the changes in ESR and ICTP, indicating an association with the inflammatory activity and processes of structural damage in the disease.
Each subject was given a detailed questionnaire at entry to the study and in the third trimester to solicit information on demographic data, house characteristics, date of the last menstrual period (LMP), medical and reproductive history, occupational hazards, alcohol consumption, and smoking practices of others present in the home.
We collected the following data from the registration: date of birth, date of entry in the study, date of and reason for leaving the registration, GP code, patient contacts (ICPC codes), prescriptions (ATC codes) and ICPC codes attached to these medications, and hospital referrals.
Patients meeting entry criteria were enrolled in the study and then followed up at specific times following completion of therapy.
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