Common use of Study Schedule Clause in Contracts

Study Schedule. The schedule of procedures and assessments during the study is summarised in Table 4 for Screening and Treatment 1 follow-up and in Table 5 for retreatment assessment and follow-up. Informed consent X Demographic data X Medical/surgical/NDO history X Prior medications and therapies X Inclusion/exclusion criteria X X X Concomitant medications and therapies X X X X X X X X X X Prior and concomitant treatments for NDO [a] X X X X X X X X X X Adverse events X X X X X X X X X X Physical examination (symptom-based) X X X ▇▇▇▇▇ ▇▇▇▇▇ X [f] X [l] X X X X Urinary tract ultrasound X [g] Urine pregnancy test [b] X X Laboratory urinalysis/microscopy [c] X X X X Urine culture [c] X X Dispense antibiotics X [i] X [n] Haematology and serum chemistry X X X Anti BTX-A antibodies X X X Dispense bladder diary & training [d] X Bladder diary review X [j] X[j] X[j] X [j] X [j] X [j] I-QoL and EQ-5D-5L X X X X mPGI-I [e] X X X X X Urodynamics (filling cystometry) X [k] X Randomisation X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. Concomitant medications and therapies X X X X X X X X X Concomitant treatments for NDO X X X X X X X X X Retreatment criteria X [e] X [e] Adverse events X X X X X X X X X Physical examination (symptom based) X X X Urine pregnancy test [a] X Laboratory urinalysis/microscopy [b] X X X X Urine culture [b] X Dispense antibiotics X [f] Haematology and serum chemistry X X X Anti BTX-A antibodies X X Bladder diary review X [g] X [g] X [g] X [g] X [g] X [g] I-QoL and EQ-5D-5L X X X X mPGI-I [c] X X X X X X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. a Pregnancy test to be performed only in females of childbearing potential. Must be performed prior to retreatment administration on the day of retreatment. b Laboratory urinalysis/microscopy and urine culture to be performed at any follow-up visit if there is a suspicion of urinary tract infection based on subject symptoms. See Section

Study Schedule. The schedule of procedures and assessments during the study is summarised in Table 4 for Screening and Treatment 1 follow-up and in Table 5 for retreatment assessment and follow-up. Informed consent X Demographic data X Medical/surgical/NDO history X Prior medications and therapies X Inclusion/exclusion criteria X X X Concomitant medications and therapies X X X X X X X X X X Prior and concomitant treatments for NDO [a] X X X X X X X X X X Adverse events X X X X X X X X X X Physical examination (symptom-based) X X X ▇▇▇▇▇ ▇▇▇▇▇ X [f] X [lm] X X X X Urinary tract ultrasound X [g] Urine pregnancy test [b] X X Laboratory urinalysis/microscopy [c] X X X X Urine culture [c] X X Dispense antibiotics X [io] X [nCCI ] Haematology and serum chemistry X X X Anti BTX-A antibodies X X X Dispense bladder diary & training [d] X Bladder diary review X [jk] X[jX[k] X[jX[k] X [jk] X [jk] X [jk] I-QoL and EQ-5D-5L X X X X mPGI-I [e] X X X X X Urodynamics (filling cystometry) X [kl] X [o] Randomisation X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. Concomitant medications and therapies X X X X X X X X X a Concomitant treatments for NDO X X X X X X X X X Retreatment criteria X [e] X [e] Adverse events X X X X X X X X X Physical examination (symptom basede.g. anticholinergics, beta-3 agonists, clean intermittent catheterisation rate) X X X Urine pregnancy test [a] X Laboratory urinalysis/microscopy [b] X X X X Urine culture [b] X Dispense antibiotics X [f] Haematology and serum chemistry X X X Anti BTX-A antibodies X X Bladder diary review X [g] X [g] X [g] X [g] X [g] X [g] I-QoL and EQ-5D-5L X X X X mPGI-I [c] X X X X X X IMP administration X BTX-A=botulinum toxin type A; EOS=End should remain stable during the first 12 weeks after Treatment 1 (preferably for the entire duration of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivitythe study). a b Pregnancy test to be performed only in females of childbearing potential. Must be performed prior to retreatment administration randomisation on the day of retreatmenttreatment. b c Laboratory urinalysis/microscopy and urine culture to be performed at any follow-up visit if there is a suspicion of urinary tract infection based on subject symptoms. See Section▇ ▇▇▇▇▇▇▇ diary device to be returned when subject completes study (e.g. in the event of screen failure, EOS Visit, Early Withdrawal Visit, etc.) e mPGI-I will be completed on the electronic bladder diary device and should be completed at home prior to the visit. f Body weight and height will be measured at Screening Visit 1 only. CCI g Urinary tract ultrasound is only required if no adequate documented urinary tract ultrasound is available in the 6 months prior to Screening (see inclusion criterion #12). h i Treatment Visit should occur within 14 days of Screening Visit 2 (where a UTI occurs and impacts the ability to perform IMP administration the time to the Treatment Visit can be extended until the UTI is resolved). Both visits may be performed on the same day, as long as all Screening Visit 2 procedures are performed prior to the Treatment Visit procedures and antibiotics were commenced 3 or more days prior to treatment. CCI j k Site should check if bladder diary has been commenced at least 8 days prior to visit. If not commenced then site should contact subject to remind subject (and/or caregiver) to commence collecting bladder diary data. Electronic bladder diary data may be reviewed by the site prior to the visit (recommended, to check if bladder diary is fully completed). CCI m At the Treatment Visit, ▇▇▇▇▇ ▇▇▇▇▇ will be recorded before and at least 30 minutes after treatment administration. In addition blood pressure and heart rate will be monitored during the entire treatment procedure in subjects with spinal cord injury with vertebral lesions above the T6 level.