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Results were monitored by an independent physician to maintain blinding of the clinical study team.
At the recommendation of the DSMB, the randomisation and labelling process was audited halfway through the study by an independent observer and found to be robust, accurate and able to maintain blinding of other study staff and participants.
All treatment questions will be directed to the interventionalists, as to maintain blinding of the assessors.
Reminders were given to nursing home staff prior to each occasion of contact to maintain blinding of data collectors.
To maintain blinding of the treatment, all patients received an intravenous infusion Q4W and two 1.2 mL subcutaneous injections Q2W.
During this examination, participants wore thin socks to obscure surgical scars and maintain blinding of the physiotherapist.
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Patients assigned to golimumab also received placebo infusions at wk16 and wk24 to maintain blinding, regardless of EE status; escalation beyond 2 mg/kg was not permitted.
To maintain blinding, the administration of the test articles were performed by investigators separate to those who assessed lameness.
The analysis and the dissemination of results were handled in a manner that maintained blinding to the individual treatment allocation of subjects, investigators and other personnel at the clinic as well as Sponsor staff.
Dosing of the gel and the capsules was individually optimized by titration to optimal effect (double-titration of capsules and gel to maintain blinding) during the first 4 weeks of the study.
Placebo-controlled, blinded trials were excluded because the regimen frequency was identical for the comparator arms (to maintain blinding) and, therefore, the impact of the placebo on adherence could not be measured.
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CEO of Professional Science Editing for Scientists @ prosciediting.com