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Subject: unique patients/ first session, pharm. A total of 23 patients have completed the FHD trial and were enrolled in the pivotal trial. All completed patients continued into the extension trial ). In summary, a total of 26 unique patients have been enrolled in the completed and ongoing ХХ trials, as per cut-off date.A total of 23 male patients with a mean age was 22 years (range: 13-54 years) received Advate® at a dose of 50 IU/kg bw in the first session, and subsequently (following a washout period of 4 days after first trial product administration) ХХ at a dose of 50 IU/kg bw (second session). Подскажите, пожалуйста, в каком смысле здесь "unique patients"? и |
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1) (отдельных - можно опустить) пациентов; 2) скорее всего, период (исследования), но лучше по дизайну уточнить. |
| спасибо, больше нигде не упоминается, по дизайну просто пациенты включаются последовательно без предусмотренных заранее групп, период в любом случае подойдет. |
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