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Englisch > Chinesisch: Medical Clinical Trial Translation Sample General field: Medizin
Ausgangstext - Englisch Randomization
At each site involved, on referral to the study, subjects will be sequentially allocated a unique identifying number to be used for all subsequent study documentation. This will ensure that confidentiality is maintained. Randomization will be stratified according to a baseline measure of the anxiety and depression subscales of the HADS. Initial stratification will be into two groups according to HADS anxiety subscale: 0–10 (normal to mild) or 11–21 (moderate to severe). Within these two groups, subjects will be further stratified into two groups categorized by HADS depression subscale: 0–10 (normal to mild) or 11–16 (moderate). This will create four strata. Within each site and within each of the four strata, randomization will occur in blocks of four in a 1:1 ratio to ensure even allocation.
Intervention
All subjects will take one blinded opaque capsule each morning on waking for 28 days. Subjects and investigators will be blinded to the medication provided. As there is a theoretical concern that SSRIs can blunt carbon dioxide sensitivity and because SSRIs are rarely tolerated at full dose when initiated without titration, therapy will be initiated at low dose with titration over 10 days. Those in the active arm will start oral ABC 15 mg daily. This dose will then double every 5 days to reach a maximum dose of ABC 60 mg daily by the beginning of day 11 if tolerated. Those in the control arm will receive an identical appearing placebo titrated over the same period of time. Participation in the study will cease if adverse events related to the study medicines develop and are unacceptable to the subject or clinician in charge of the subject’s care.
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