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Table 1 Patient demographics and baseline characteristics (V-2), N = 39 (ITT)

From: Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence

Characteristic Value
Age (years), mean (SD) 60.6 (13.81)
Height (cm), mean (SD) 166.3 (6.82)
Weight (kg), mean (SD) 68.5 (14.53)
BMI (kg/m2), mean (SD) 24.7 (4.21)
Gender, n (%)
 Female 34 (87.2)
 Male 5 (12.8)
History of anorectal surgeries (including anal sphincter surgery)a, n (%) 2 (5.13)
FI episodes
 Time since first diagnosis (months), mean (SD) 128.3 (109.96)
 Cause of FIb,c, n (%)
  Muscle damage only 16 (41.03)
  Atrophy only 17 (43.59)
  Both 6 (15.38)
CGI score by investigatord
 Moderately ill 2 (5.1)
 Markedly ill 14 (35.9)
 Severely ill 17 (43.6)
 Among the most extremely ill 6 (15.4)
  1. V-2 3 months pre implantation, N number of values, ITT intention to treat, SD standard deviation, BMI body mass index, n number of patients, FI faecal incontinence, CGI Clinical Global Impression
  2. aEarlier than 6 months before screening and no more than two surgeries (otherwise not included)
  3. bMultiple answers possible
  4. cAccording to medical history, in none of the patients was FI associated with constipation, diarrhoea, pelvic floor dysfunction, nerve damage or loss of storage capacity
  5. dCGI scores: normal, not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients [38]