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In part 2 (beginning after part 1 enrolment ended), newly enrolled patients received TCZ 4 or 8 mg/kg or placebo for 24 weeks.
Exclusion criteria: no Informed Consent available; bacterial upper respiratory tract infection; antibiotic therapy at time of visit 1 (enrolment) or necessity for an antibiotic therapy; symptoms that were present since more than 3 days.
The inclusion diagnoses were acute pharyngitis, acute tonsillitis, acute laryngitis and tracheitis, acute tracheitis, acute laryngotracheitis, acute laryngopharyngitis with at least two ARI episodes in the last 6 months prior to visit 1 (enrolment); previous ARI episodes had to be documented in the patient source documents.
The study consisted of a seven-day treatment period of Canephron® N and a follow-up period until Day 37. Three visits were planned on Day 0 (Visit 1: Enrolment, start of treatment), Day 7 ± 1 day (Visit 2: End of treatment) and Day 37 ± 1 day (Visit 3: End of study).
In part 1, enrolment of 3150 patients was planned for the detection of small differences in EULAR response between treatment subgroups.
– Visit 1 (Enrolment, -7/-10 days) At enrolment, before receiving any intervention, caregivers of patients provided information on demographics and medical history, and a physical examination including rectal digital examination (if needed) was performed.
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Serum samples were collected on the first day of gametocytaemia and 28 and 84 days post-enrolment (or d7, 28, 84 after enrolment from gametocyte-negative individuals).
POISE-2 enrolment began in July 2010, and enrollment in the POISE-2 AKI substudy began in January 2011.
Each patient enrolled in the study was sampled for three sera (S1 S3); enrolment day 0 (sampleample 2 (S2) collected 6 8 weeks after enrolment and a third sample (S3) 6 months after enrolment.
Fig. 3 Enrolment hours × qualification level interaction.
Led by Elias Bou Saab, the Ministry of Education has delivered transformational results - over 200,000 Syrian children in formal schools achieved through the 2015/16 enrolment campaign.
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