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After a screening period of at least 3 days (to allow for assessment of the PPD tuberculin skin test administered at the study entry visit), all patients self-administered adalimumab 40 mg subcutaneously every other week (eow) in addition to their pre-existing antirheumatic therapy.
All treatment sessions were administered at the study site.
Additional i.v. fluids were administered at the study physicians' discretion.
Injections at baseline and week 24 were administered at the study centre; other injections could be administered in the patient's home as part of the patient's regular care.
The allocation sequence was determined dynamically using a database independently administered at the study's Clinical Trials Unit; the database incorporated a study-specific version of a published dynamic randomisation allocation method, 65 and the resulting allocations were then sent by email to the Trial Manager for further dissemination to study therapists.
The primary outcome of product acceptability was examined separately for the diaphragm and for the gel using a variable from the MIRA main study acceptability questionnaire administered at the study's closing visit: "How would you rate the [diaphragm/gel] overall?": "strongly like, like, dislike, strongly dislike".
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The Wechsler Intelligence Scale for Children-IV (WISC-IV) was administered at the initial study visit at the time of biological sample collection.
The survey administered at the conclusion of the study period adds to these findings.
To assess the secondary outcome, the Clinical Global Impression Scale CGII) [ 24], the SDS, and the Self-Report for the Assessment of Adjustment Disorders [ 25] were also administered at these study visits.
A participatory survey was administered at the end of the study.
This 1-day examination was administered at the institution of study in October of 2007.
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