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English to Chinese: Medical Clinical Trial Translation Sample General field: Y khoa
Văn bản nguồn - English 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.
Bài dịch - Chinese 随机化
在每个研究中心，受试者被转介到研究时，将按顺序为其分配一个唯一的识别号，用于所有后续的研究文件记录，以确保机密性。将根据HADS焦虑与抑郁分量表的基线测量值进行分层随机化。根据HADS焦虑分量表进行初始分层，划分为两个组：0-10分（正常至轻度）或11-21分（中度至重度）。然后，在这两个组中，按照HADS抑郁分量表分类，对受试者进一步分层，划分为两个组：0-10分（正常至轻度）或11-16分（中度）。将创建4个层。在每个研究中心和4个层的每个层中，按1:1的比例在4个区组中进行随机化，以确保平均分配。
Thành viên kể từ Jun '23
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