Randomization for treatment order (placebo–active drug/active drug–placebo) is performed by a coin flip done by a research coordinator assigned for this task who is not involved in patient interaction and outcome assessment. The same coordinator also ensures blinding by assigning a three-digit number code, from a computer-generated random list, to the Topi-Pumps used in each treatment block. The list of number codes and the identity of their corresponding treatment is only shared with the compounding pharmacy. The blinding applies to the patient, the study coordinator performing patient assessments, and the dispensing pharmacy.

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