Randomization and intervention
Eligible participants were randomly assigned in a 1:1:1 ratio (Fig. Screening, randomization, and follow-up. Participants who completed at 48 weeks are considered to have completed the trial (per protocol population). The modified intention-to-treat population which included participants with at least one dose of neuroEPO plus or placebo and a baseline measurement based on randomized treatment. The per protocol population which included subjects who complied with the protocol sufficiently (more than 90% of treatment with efficacy outcomes at baseline and at 48 weeks without any major deviation of protocol) to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model. Subjects were considerate in their randomized group. The safety population included participants who received at least one dose of neuroEPO or placebo. SPECT denotes single-photon emission computed tomographyRandomized participants received either neuroEPO plus 0.5 mg or neuroEPO plus 1.0 mg or placebo 3 times a week (Monday, Wednesday, and Friday), during 4 weeks. In order to keep the blinding, placebo was divided, and a half received 0.5 mL and the other 1.0 mL. From the 5 to 48 weeks, neuroEPO plus groups received 0.5 mg and placebo group received 0.5 mL.