Recruitment and informed consent
RECRUITMENT
The primary method for recruiting potential subjects was a Minneapolis VA Health Care System (MVAHCS) Investigational Review Board (IRB)-approved recruitment letter sent to Gulf War Veterans listed in the MVAHCS Persian Gulf War Registry. Interested Veterans called the MVAHCS Gulf War Hotline. After the initial medication questions, Veterans answered the Kansas GWI Case Definition questionnaire. In addition to meeting the Kansas criteria, subjects had to be willing to make several trips to the MVAHCS for study visits and to take the study drug or placebo as directed. The recruitment period for this study was from July 1, 2015, to December 31, 2019. The final study visit of the last subject was on April 6, 2020. The process of obtaining informed consent began at the initial appointment and was performed in accordance with good clinical practices guidelines. The GWIIRT protocol, informed consent documents, and waivers for the screening were approved by the MVAHCS IRB.