Blinding.
ADVERSE EFFECTS
Participants and investigators performing assessments were blinded to intervention assignments. After the first 4 participants, there was an interim unblinding to confirm intervention safety. Blinding was reestablished for the remaining 24 participants until after the main analyses were completed. During the 8-week active study period, adverse effects were monitored by a designated unblinded investigator, our statistician, and clinical pharmacist.