In addition, Clinical Global Impression of Change (CGIC) and Patient's Global Impression of Change (PGIC) were assessed at study termination or completion.
The final dose-maintenance period visit was at week 10, with participants who did not complete the study assessed at an early termination (ET) visit.
Health-related quality of life was assessed at screening, 6 months and at termination using the EQ-5D 15, Haem-A-QoL 16, Haemo-QoL 17, and visual analogue scale (VAS) for general pain assessment 18, 19.
Adverse events were assessed at each treatment visit, treatment termination, and during follow-up.
Patient satisfaction with treatment was assessed at month 6 or at early termination 10 using the following question on a five-point scale: "how would you rate your satisfaction with the treatment you received?": excellent, 1; very good, 2; good, 3; fair, 4; or poor, 5. Responses were dichotomisd as follows: 1, 2, 3 (favourable) versus 4, 5 (not favourable).
Vaccine titres against tetanus toxoid, diphtheria and pneumococcus were assessed at baseline and week 52 (or early termination).
All PROs measures were assessed at baseline and at Week 12 (or early termination, if applicable).
The UPDRS, PGI, and PDQ-39 were assessed at months 1, 5, and 9 (or early termination).
The SF-36, FACIT-F, and MOS Sleep Scale were assessed at baseline, months 3 and 6, and/or early termination.
Body weight gain did not differ between the animal groups, when assessed at the time of MNU injection and at the termination of the experiment (Table 1).
