Table 4.

Primary and secondary efficiency criteria of the four studies

Phloroglucinol solution for IV and IM administration in biliary tract	Primary efficiency criteria
	Complete relief from pain, according to the patient’s subjective evaluation of their condition by the following rating scales: VAS and VRS after the first or repeated injection on the first day of treatment
	Secondary efficiency criteria
	Onset of painkilling effect, according to the patient’s evaluation of their pain by a VAS and VRS every 15 min for 60 min after administration of the study drug
	Absence of occurrence of repeated pain episodes or spastic phenomena during the follow-up period
	Need for repeated injections of the drug
	Elimination of spasm and improvement in gallbladder outflow and motor function of the gallbladder and ducts—according to ultrasound or CT* or plain film*
Phloroglucinol solution for IV and IM administration in urinary tract	Primary efficiency criteria
	Difference between the two groups in the intensity of pain (PID) according to the subjective assessment by the patient of the pain syndrome by the VAS in millimetres. A significant difference between the groups is a difference of 13 mm or more on the VAS at 30 min after intravenous injection on the first day of the study and at 60 min after intramuscular injection on the second and consecutive days of the study
	Secondary efficiency criteria
	Assessment by the patient of relief from the pain syndrome according to the VRS in points, after 30 and 60 min (the first day of the study) and 60 min (the second and consecutive days of the study) after injection of the drugs, for a preliminary evaluation of the therapy efficiency, as an additional measure of pain assessment; to decide whether to increase repeated injections (the first day of study) or to exclude the patient from the study in the absence of the therapy efficiency. Any improvement on the VRS at least by 1 point will be considered a positive response to therapy
	Assessment of pain intensity on the VAS in millimetres, in comparison with the baseline at 30 min after injection on the first day of the study or at 60 min after injection on the second and consecutive days of the study, to calculate PID. Reduction of pain intensity on the VAS 60 min after the first injection to assess the stability of the effect on the first day of the study
	Absence of recurrent colic during follow-up during the entire study period
	Elimination of spasm and recovery of urine passage—according to ultrasound examination of kidneys and bladder, a plain film of the urinary tract* or CT of the urinary tract*
	Discharge of concernment
Phloroglucinol + 1,3,5-trimethoxybenzene tablets in biliary tract	Primary efficiency criteria
	Relief from the pain syndrome according to the patient’s assessment of their condition on the VAS and digital rating scale of the pain assessment prior to taking the drug and 1 h after taking the drug, during the entire treatment period
	Secondary efficiency criteria
	Elimination of spasm and improvement in gallbladder outflow and motor function of the gallbladder and ducts
	According to ultrasound* or CT* of the ducts and gallbladder
Phloroglucinol + 1,3,5-trimethoxybenzene tablets in urinary tract	Primary efficiency criteria
	Difference between the two groups in the intensity of pain (PID) according to the subjective assessment by the patient of the pain syndrome by the VAS in millimetres. A significant difference between the groups is a difference of 13 mm or more on the VAS, 60 min after the intake of the drugs
	Secondary efficiency criteria
	Assessment by the patient of relief from the pain syndrome according to the VRS in points, 60 min after taking the drugs, for a preliminary evaluation of the therapy efficiency, as an additional measure of pain assessment; to decide whether to increase the dose of the drug or to exclude the patient from the study in the absence of the therapy efficiency. Any improvement on the VRS at least by 1 point will be considered a positive response to therapy
	Elimination of spasm and recovery of urine passage according to ultrasound examination of kidneys and bladder (compulsory method), a plain film of the urinary tract* or CT of the urinary tract*
	Discharge of concernment

CT computed tomography, PID pain intensity difference, VAS visual analogue scale, VRS verbal rating scale

*Optional method, as determined by the clinical investigator