Table 2.

The ADRESU study data collection schedule

	Screening period		Operation	Observation period
	Provisional registration	Registration	Day 0	Day 1	At end of hospitalization	Week 2	Week 4	Week 12	Week 26	Week 38	Week 52
Eligibility criteria	X	X
Vital signsa			X	X	X	X
Oxygen saturation			X	X	X	X
Laboratory tests
Infectionsb		X
Hematologyc, Biochemistryd, CRP, Coagulatione, Urinalysisf		X		X	X	X	X	X	X		X
PSA		X						X	X		X
12 Lead electrocardiography		X		X	X	X
Chest X-rays		X
Urination diaryg		X				X	X	X	X	X	X
QOL scoresh		X							X		X
Patient overall satisfaction		X							X		X
Urodynamic parametersi		X				X	X	X	X		X
Transrectal ultrasonography		X						X	X		X
MRI		X				X			X		X
Liposuction			X
Periurethral injection of ADRCs, and mixture of ADRCs and fat			X
Concomitant therapies	X	X	X	X	X	X	X	X	X	X	X
Adverse events	X	X	X	X	X	X	X	X	X	X	X

^a Blood pressure, pulse rate, body temperature

^b HBs antigen, HCV antibody, HIV antibody, serologic test of syphilis

^c Red blood, hemoglobin, hematocrit, white blood cell count, fraction of leucocytes (basophil, eosinophil, neutrophil, lymphocyte, monocyte), platelet count

^d Total protein, albumin, total cholesterol, blood urea nitrogen, creatinine, uric acid, sodium, chloride, potassium, calcium, phosphate, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, creatinine kinase

^e Prothrombin time, activated partial thromboplastin time, fibrinogen

^f pH, protein, glucose, urobilinogen, occult blood

^g Urine leakage volume, number of incontinence episodes, number of pads used

^h International Consultation on Incontinence Questionnaire-Short Form, King’s Health Questionnaire

ⁱ Maximum urethral closing pressure, functional profile length, abdominal leak point pressure

Abbreviations: CRP C-reactive protein, PSA Prostate-Specific Antigen, QOL quality of life, MRI magnetic resonance imaging, ADRCs adipose-derived regenerative cells