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Physiotherapists will be supplied with weights and elastic bands to provide to the study participants.
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Additional credibility could have been provided to the study if a control group of patients undergoing longer periods of immobilization had been included.
Sealed opaque envelopes containing the study medication assignment for each subject were provided to the study site investigator for use in an emergency; no code breaks were required.
Pre-HIV test counselling was provided to the study subjects.
A monthly report on recruitment, study participations and completion will be provided to the study PI.
The CCHMC IRB was notified of all materials provided to the study families.
The allocation is also immediately provided to the study coordinator by confidential fax.
Scores were revised based on vendor feedback and these were provided to the study guidance group for review and approval.
Once compiled at the program, the list of names of potential study volunteers was provided to the study team by the program director.
Finally, feedback of the findings was provided to the study hospitals and the relevant ethical bodies to ensure credibility of the results.
The blind identifiers of selected subjects were provided to the study sponsor, who managed the shipment of plasma samples to the participating laboratories.
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