Procedures
NPS, sleep disturbance, anxiety, Pain, fatigue, pain, depression
BLOOD, ADVERSE EVENT
Pain intensity scores using the 24-hour 11-point NPS were collected daily using an E-diary during parts A and B. Participants were required to record their pain intensity scores for a minimum of 6 of 7 days before screening/enrollment, and then three times per day throughout the study. Pain intensity was evaluated on the affected limb. If more than one limb was involved, the participant and investigator determined which limb was the most affected and pain intensity was evaluated for that limb throughout the study. E-diaries had time-limited response windows and were available to the investigators in real time. Investigators were asked to call participants if they did not complete their daily E-diary.The PROMIS-29 (version 2.1), PGI-C, and CSS were completed at screening, and at weeks 15 and 29. The PROMIS-29 is a generic health-related quality-of-life survey with seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Answers were ranked by the participant on a 5-point Likert scale. Total raw domain scores were converted into T-scores using a conversion table based on data from a reference population [Blood samples (two 4 mL samples) to determine plasma 24HC levels were collected on day 1 (pre-dose and 1 hour post-dose) and weeks 2, 7, and 29 (1 hour post-dose). Adverse events were collected throughout the study until early termination or last follow-up visit (week 29), and the C-SSRS was assessed at baseline and weeks 1, 2, 3, 7, 11, and 15.