Trial Outcomes & Findings for Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy (NCT NCT01056341)

NCT ID: NCT01056341

Last Updated: 2015-12-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 512 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-12-10

Participant Flow

512 patients were included in the study (informed Consent Form signed). Among these 510 patients, 460 were randomized and 52 were screen failure * At least one inclusion criterion not met in 26 cases * Parent's decision in 12 cases * Other reasons in 15 cases. One patient was not included for two reasons (Parent's decision and other reason)

Participant milestones

Measure	Placebo Placebo: Treatment with placebo for 6 months	Propranolol 1mg/kg/d 3 Months Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months	Propranolol 1 mg/kg/d 6 Months Propranolol oral solution 1mg/kg/day for 6 months	Propranolol 3 mg/kg/d 3 Months Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months	Propranolol 3 mg/kg/d 6 Months Propranolol oral solution 3mg/kg/day for 6 months
Overall Study STARTED	55	99	103	101	102
Overall Study Interim Analysis	25	41	41	40	43
Overall Study COMPLETED	19	63	88	65	88
Overall Study NOT COMPLETED	36	36	15	36	14

Reasons for withdrawal

Measure	Placebo Placebo: Treatment with placebo for 6 months	Propranolol 1mg/kg/d 3 Months Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months	Propranolol 1 mg/kg/d 6 Months Propranolol oral solution 1mg/kg/day for 6 months	Propranolol 3 mg/kg/d 3 Months Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months	Propranolol 3 mg/kg/d 6 Months Propranolol oral solution 3mg/kg/day for 6 months
Overall Study Treatment Intolerance	0	2	0	2	0
Overall Study Lack of Efficacy	32	30	7	25	9
Overall Study Other reasons	4	4	8	9	5

Baseline Characteristics

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

Baseline characteristics by cohort

Measure	Placebo n=55 Participants Placebo: Treatment with placebo for 6 months	Propranolol 1mg/kg/d 3 Months n=98 Participants Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months	Propranolol 1 mg/kg/d 6 Months n=102 Participants Propranolol oral solution 1mg/kg/day for 6 months	Propranolol 3 mg/kg/d 3 Months n=100 Participants Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months	Propranolol 3 mg/kg/d 6 Months n=101 Participants Propranolol oral solution 3mg/kg/day for 6 months	Total n=456 Participants Total of all reporting groups
Age, Continuous	103.91 DAYS STANDARD_DEVIATION 31.06 • n=5 Participants	103.58 DAYS STANDARD_DEVIATION 33.07 • n=7 Participants	102.65 DAYS STANDARD_DEVIATION 30.12 • n=5 Participants	107.53 DAYS STANDARD_DEVIATION 30.14 • n=4 Participants	101.63 DAYS STANDARD_DEVIATION 31.00 • n=21 Participants	103.85 DAYS STANDARD_DEVIATION 31.02 • n=10 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	68 Participants n=7 Participants	70 Participants n=5 Participants	79 Participants n=4 Participants	70 Participants n=21 Participants	325 Participants n=10 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	30 Participants n=7 Participants	32 Participants n=5 Participants	21 Participants n=4 Participants	31 Participants n=21 Participants	131 Participants n=10 Participants
Region of Enrollment United States	6 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	11 participants n=4 Participants	10 participants n=21 Participants	53 participants n=10 Participants
Region of Enrollment Spain	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants	17 participants n=4 Participants	14 participants n=21 Participants	59 participants n=10 Participants
Region of Enrollment Lithuania	1 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants	18 participants n=10 Participants
Region of Enrollment Russian Federation	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	3 participants n=10 Participants
Region of Enrollment Italy	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	2 participants n=10 Participants
Region of Enrollment France	21 participants n=5 Participants	25 participants n=7 Participants	18 participants n=5 Participants	22 participants n=4 Participants	28 participants n=21 Participants	114 participants n=10 Participants
Region of Enrollment Czech Republic	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	8 participants n=10 Participants
Region of Enrollment Hungary	1 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	11 participants n=10 Participants
Region of Enrollment Mexico	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	0 participants n=21 Participants	5 participants n=10 Participants
Region of Enrollment Canada	2 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	2 participants n=21 Participants	18 participants n=10 Participants
Region of Enrollment Poland	4 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	8 participants n=4 Participants	4 participants n=21 Participants	26 participants n=10 Participants
Region of Enrollment Romania	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	7 participants n=10 Participants
Region of Enrollment Peru	1 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	12 participants n=21 Participants	35 participants n=10 Participants
Region of Enrollment Australia	1 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants	5 participants n=4 Participants	7 participants n=21 Participants	32 participants n=10 Participants
Region of Enrollment Germany	8 participants n=5 Participants	17 participants n=7 Participants	9 participants n=5 Participants	17 participants n=4 Participants	9 participants n=21 Participants	60 participants n=10 Participants
Region of Enrollment New Zealand	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants	5 participants n=10 Participants
Infantile hemangioma localization FACE	40 participants n=5 Participants	71 participants n=7 Participants	72 participants n=5 Participants	64 participants n=4 Participants	71 participants n=21 Participants	318 participants n=10 Participants
Infantile hemangioma localization NONE FACE	15 participants n=5 Participants	27 participants n=7 Participants	30 participants n=5 Participants	36 participants n=4 Participants	30 participants n=21 Participants	138 participants n=10 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.

Outcome measures

Measure	Placebo n=25 Participants Placebo: Treatment with placebo for 6 months	Propranolol 1mg/kg/d 3 Months n=41 Participants Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months	Propranolol 1 mg/kg/d 6 Months n=40 Participants Propranolol oral solution 1mg/kg/day for 6 months	Propranolol 3 mg/kg/d 3 Months n=39 Participants Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months	Propranolol 3 mg/kg/d 6 Months n=43 Participants Propranolol oral solution 3mg/kg/day for 6 months
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.	8.0 percentage of participants	9.8 percentage of participants	37.5 percentage of participants	7.7 percentage of participants	62.8 percentage of participants

PRIMARY outcome

Timeframe: 6 months

Population: After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.

Outcome measures

Measure	Placebo n=55 Participants Placebo: Treatment with placebo for 6 months	Propranolol 1mg/kg/d 3 Months n=101 Participants Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months	Propranolol 1 mg/kg/d 6 Months Propranolol oral solution 1mg/kg/day for 6 months	Propranolol 3 mg/kg/d 3 Months Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months	Propranolol 3 mg/kg/d 6 Months Propranolol oral solution 3mg/kg/day for 6 months
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.	3.6 percentage of participants	60.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 6 months

Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits

Outcome measures

Outcome data not reported

Adverse Events

W24-treatment Period-safety Set-Placebo

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months

Serious events: 5 serious events

Other events: 88 other events

Deaths: 0 deaths

W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months

Serious events: 3 serious events

Other events: 92 other events

Deaths: 0 deaths

W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months

Serious events: 9 serious events

Other events: 92 other events

Deaths: 0 deaths

W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months

Serious events: 5 serious events

Other events: 96 other events

Deaths: 0 deaths

W72-follow-up Period of ex Placebo Group-safety Set

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set

Serious events: 6 serious events

Other events: 66 other events

Deaths: 0 deaths

W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set

Serious events: 5 serious events

Other events: 70 other events

Deaths: 0 deaths

W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set

Serious events: 7 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Measure	W24-treatment Period-safety Set-Placebo n=55 participants at risk Placebo: Treatment with placebo for 6 months	W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months n=98 participants at risk Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months	W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months n=102 participants at risk Propranolol hydrochloride oral solution 1mg/kg/day for 6 months	W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months n=100 participants at risk Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months	W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months n=101 participants at risk Propranolol hydrochloride oral solution 3mg/kg/day for 6 months	W72-follow-up Period of ex Placebo Group-safety Set n=33 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set n=85 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set n=91 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set n=87 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set n=95 participants at risk 72-week follow-up period without study treatment administration
Injury, poisoning and procedural complications Traumatic brain injury	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Psychiatric disorders Apathy	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Cardiac disorders Atrioventricular block second degree	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Cardiac disorders Bradycardia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Bronchiolitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.1% 2/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Bronchitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Bronchopneumonia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders Condition aggravated	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Cardiac disorders Cyanosis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Cystitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders Drug ineffective	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Enterocolitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Nervous system disorders Epilepsy	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Gastroenteritis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures Ileostomy closure	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Pyelonephritis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders Pyrexia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Rotavirus infection	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.3% 2/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Viraemia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures cataract operation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Metabolism and nutrition disorders dehydration	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures surgery	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures Finger amputation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures hip surgery	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures hospitalisation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Surgical and medical procedures scrotal operation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Congenital, familial and genetic disorders hip dysplasia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders asphyxia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Nervous system disorders convulsion	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Nervous system disorders febrile convulsion	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders inflammation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders hyperthermia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Metabolism and nutrition disorders ketoacidosis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Metabolism and nutrition disorders type 1 diabetes mellitus	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations respiratory tract infection viral	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations ear infection	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations gastroenteritis rotavirus	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations nasopharyngitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations otitis media acute	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations respiratory syncytial virus infection	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations tonsillitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations pneumonia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.4% 2/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.

Other adverse events

Measure	W24-treatment Period-safety Set-Placebo n=55 participants at risk Placebo: Treatment with placebo for 6 months	W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months n=98 participants at risk Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months	W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months n=102 participants at risk Propranolol hydrochloride oral solution 1mg/kg/day for 6 months	W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months n=100 participants at risk Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months	W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months n=101 participants at risk Propranolol hydrochloride oral solution 3mg/kg/day for 6 months	W72-follow-up Period of ex Placebo Group-safety Set n=33 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set n=85 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set n=91 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set n=87 participants at risk 72-week follow-up period without study treatment administration	W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set n=95 participants at risk 72-week follow-up period without study treatment administration
Vascular disorders Peripheral coldness	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 8/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.8% 10/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.9% 10/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Bronchiolitis	5.5% 3/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.1% 5/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.9% 7/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.0% 5/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.9% 9/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.1% 6/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.3% 9/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	11.6% 11/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Bronchitis	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.1% 5/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.8% 8/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.0% 10/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	15.8% 16/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.1% 3/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	14.1% 12/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	15.4% 14/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	20.7% 18/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	21.1% 20/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Eye disorders Conjunctivitis	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.1% 4/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.8% 8/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.9% 8/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 7/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.8% 8/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 7/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.5% 9/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Constipation	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.2% 9/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.0% 9/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 4/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	14.3% 14/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	17.6% 18/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.0% 16/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	13.9% 14/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.1% 4/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.4% 8/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.5% 5/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 7/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.4% 7/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Skin and subcutaneous tissue disorders Dermatitis diaper	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.1% 4/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.9% 5/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.9% 9/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.7% 4/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.2% 2/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.4% 3/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.2% 3/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Diarrhea	7.3% 4/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.3% 16/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	13.7% 14/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	17.0% 17/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	27.7% 28/101 • Number of events 51 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.7% 4/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	11.5% 10/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.5% 9/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Ear infection	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.1% 7/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.0% 7/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	18.2% 6/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	15.3% 13/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	14.3% 13/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.1% 14/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	17.9% 17/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Skin and subcutaneous tissue disorders Eczema	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 8/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.9% 4/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.7% 4/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.2% 2/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.6% 4/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.2% 4/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Gastroenteritis	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.9% 5/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.9% 11/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.1% 4/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 7/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.9% 9/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.1% 14/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	14.7% 14/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Psychiatric disorders Insomnia	5.5% 3/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.1% 3/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders Irritability	5.5% 3/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.1% 5/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Psychiatric disorders Middle insomnia	5.5% 3/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 6/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.9% 4/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.0% 7/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Nasopharyngitis	18.2% 10/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	29.6% 29/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	20.6% 21/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	32.0% 32/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	33.7% 34/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	24.2% 8/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	30.6% 26/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	22.0% 20/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	27.6% 24/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	31.6% 30/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders Pyrexia	10.9% 6/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	21.4% 21/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	23.5% 24/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	22.0% 22/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	27.7% 28/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	18.2% 6/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	24.7% 21/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.5% 15/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	23.0% 20/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	25.3% 24/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Rhinitis	9.1% 5/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	13.3% 13/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.7% 13/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.0% 5/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.0% 5/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.1% 3/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.6% 9/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.7% 7/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.3% 6/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.1% 3/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.9% 3/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 8/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.4% 3/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.3% 5/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Psychiatric disorders Sleep disorder	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.2% 12/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.9% 7/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Nervous system disorders Somnolence	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 6/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.9% 4/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Teething	10.9% 6/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	19.4% 19/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	22.5% 23/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.0% 16/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	21.8% 22/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 5/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.9% 9/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 7/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.4% 8/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Toothhache	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.1% 5/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 8/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.9% 10/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.2% 4/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations Upper respiratory tract infection	7.3% 4/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 6/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.7% 13/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	20.0% 20/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	15.8% 16/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	15.2% 5/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 7/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.5% 15/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	14.9% 13/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	11.6% 11/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Injury, poisoning and procedural complications Vaccination complication	3.6% 2/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.1% 7/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.8% 9/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 8/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	7.9% 8/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.3% 2/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.1% 2/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders Vomiting	5.5% 3/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	16.3% 16/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.7% 13/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.0% 10/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	12.9% 13/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.5% 3/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.3% 3/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.6% 4/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.1% 2/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders nasal congestion	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.1% 3/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.4% 2/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.3% 3/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.7% 5/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.3% 5/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Nervous system disorders hypotonia	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
General disorders condition aggravated	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.1% 3/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.2% 3/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Psychiatric disorders agitation	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 6/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Gastrointestinal disorders gingival pain	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.1% 3/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.0% 5/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Skin and subcutaneous tissue disorders dermatitis atopic	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.3% 2/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.1% 2/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Metabolism and nutrition disorders decreased appetite	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.1% 5/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.9% 3/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.0% 5/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations tonsillitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.1% 3/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.2% 7/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.6% 6/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.0% 7/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	10.5% 10/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations pharyngitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.1% 4/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.9% 3/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 5/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.9% 6/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	8.4% 8/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations otite media	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	18.2% 6/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 5/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.6% 4/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.3% 5/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations influenza	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.9% 3/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 3/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.0% 4/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.4% 2/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.3% 2/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.3% 5/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations varicella	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.9% 5/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.4% 4/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.9% 6/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.2% 4/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations roseola	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.0% 1/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.5% 3/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	5.5% 5/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	4.2% 4/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations hand-foot-and-mouth disease	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.2% 2/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.4% 3/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	3.2% 3/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations acute tonsillitis	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.0% 2/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	2.1% 2/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations croup infectious	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.0% 1/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations eye infection	1.8% 1/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.98% 1/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	9.1% 3/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.1% 1/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Infections and infestations gastroenteritis viral	0.00% 0/55 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/98 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/102 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/100 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.99% 1/101 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	6.1% 2/33 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	1.2% 1/85 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/91 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/87 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.	0.00% 0/95 • Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks). Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo. Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.

Additional Information

Dr. Jean-Jacques VOISARD - General Manager -

Pierre Fabre Dermatologie

Phone: +33 5 63 58 88 00

Email: jean.jacques.voisard@pierre-fabre.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigators can reserve the right to publish or present study data; provided that the sponsor reviews the abstract or manuscript at least 60 days prior to the expected date of submission to the intended publisher or planned presentation. Publication of study results by each site shall be made only after completion and finalisation of the study by all sites and first publication by the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER