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In this study, we maintained blinded study protocol for the involved investigators, to diminish the inherent bias in the selection and to reach certainty and maintain internal validity of the results.
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The sponsor maintained blinding in all communications with investigators and other site personnel.
For this analysis, we maintained blinding using the procedures described below.
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.
The lithium and placebo capsules were identical in appearance, smell, and taste to maintain blinding.
When an eligible subject was recruited, the pharmacist allocated the subject to the designated treatment group, maintaining blinding.
The single-dose group received an infusion of gentamicin and clindamycin, followed by an administration of intravenous placebo 8 and 16 hours later to maintain blinding.
Patients received ibandronate IV injections 2 mg every 2 months, 3 mg every 3 months or oral ibandronate 2.5 mg daily, plus oral or IV placebo, as appropriate to maintain blinding.
Matching placebos were administered to maintain blinding.
Instructions were also given to the referent member to maintain blinding during the telephone interview.
Results were monitored by an independent physician to maintain blinding of the clinical study team.
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CEO of Professional Science Editing for Scientists @ prosciediting.com