Trial design
BLIND
A prospective randomized, single blind (outcomes assessors), controlled trial was conducted at the Shamir Medical Center (SMC), Israel. After signing an informed consent, patients were randomized to either HBOT or pharmacological intervention groups in a 1:1 ratio according to a computerized randomization table, supervised by a blinded researcher. Evaluation was performed at baseline for both groups and 1–3 weeks after the last HBOT session or three months of medications protocol. All evaluators were blinded to the patients’ group allocation. Intention to treat analysis was performed on all included patients. The study was approved by Shamir Medical Center’s institutional review board (IRB) (No. 058-17-ASF) and all participants signed an informed consent prior to their inclusion. All research was performed according to the relevant guidelines and regulations. This study was registered with ClinicalTrials.gov, number NCT03325959 on 30/10/2017.