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Because the active control bottle (Xalatan) was visibly different than the investigational bottles, a designee at each study site, other than the investigator, was responsible for the dispensing study treatment at Visit 3, instructing patients on proper instillation of study medication, and retrieval of materials at the end of the study.
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The interactive voice response group programmed the randomization schedule for investigators to dispense study drug.
Each patient was asked to return the previously dispensed study drug bottle for documentation of study drug compliance.
A whanau (support) worker is employed to assist with recruitment, informed consent, and to deliver and dispense study medication.
Patients were dispensed study medication kits containing unit-dose containers (each for single use) that were identical for both formulations.
At numerous communities, local community workers are employed to locate the children weekly and dispense study medication.
A responsible party was required to accompany the participant during study visits, to provide reliable assessments, and to dispense study medications.
Patients were dispensed study medication kits containing unit-dose (single-use) containers that were identical for both formulations, thereby ensuring masking of patients, investigators and evaluators.
For each visit, we will check eligibility, end points/outcome measures, safety (general and specific safety assessments, e.g. specific laboratory tests), adverse event collection, dispensing of study drugs, compliance with study drugs, recording of concomitant medications, and laboratory tests to evaluate treatment response as defined in the schedule.
In our study each questionnaire was administered twice before and after dispensing the study garments with the results averaged, in the hopes of increasing the precision of the pain assessments.
The University of Michigan Investigational Drug Service (UM IDS) was responsible for dispensing all study medication.
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