Trial Outcomes & Findings for CLARITY Extension Study (NCT NCT00641537)

Last Updated: 2020-12-07

Results Overview

Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events v 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

867 participants

Primary outcome timeframe

Baseline up to Week 120

Results posted on

2020-12-07

Participant Flow

A total of 1326 subjects were randomized into CLARITY from study 25643 (NCT00213135), of whom 867 consented to participate in this phase 3b extension Study 27820. 806 subjects were randomized or assigned to treatment and a further 61 subjects were followed for safety only (Supplemental follow-up period \[no study treatment\] \[SAFUP\]).

Participant milestones

Participant milestones
Measure	Cladribine Low/Placebo (LLPP) Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/No Treatment Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 3.5 mg/kg/No Treatment Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 5.25 mg/kg/No Treatment Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
96-week Period STARTED	98	92	186	186	244	22	17	22
96-week Period COMPLETED	89	82	166	174	227	15	12	16
96-week Period NOT COMPLETED	9	10	20	12	17	7	5	6
24-Week Supplemental Follow-up Period STARTED	75	69	143	151	198	15	9	11
24-Week Supplemental Follow-up Period COMPLETED	75	66	140	147	193	14	8	10
24-Week Supplemental Follow-up Period NOT COMPLETED	0	3	3	4	5	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cladribine Low/Placebo (LLPP) Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/No Treatment Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 3.5 mg/kg/No Treatment Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 5.25 mg/kg/No Treatment Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
96-week Period Adverse Event	0	1	3	0	2	0	0	0
96-week Period Lost to Follow-up	3	1	2	2	4	0	1	0
96-week Period Protocol Violation	0	1	0	1	0	1	0	0
96-week Period Death	2	0	1	0	0	0	0	0
96-week Period Other	4	7	14	9	11	6	4	6
24-Week Supplemental Follow-up Period Lost to Follow-up	0	1	1	3	2	1	0	0
24-Week Supplemental Follow-up Period Other	0	2	2	1	3	0	1	1

Baseline Characteristics

CLARITY Extension Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cladribine Low/Placebo (LLPP) n=98 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Total n=806 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	40.8 years STANDARD_DEVIATION 9.6 • n=7 Participants	40.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	41.4 years STANDARD_DEVIATION 10.1 • n=4 Participants	41.6 years STANDARD_DEVIATION 9.6 • n=21 Participants	41.1 years STANDARD_DEVIATION 10.1 • n=8 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	59 Participants n=7 Participants	124 Participants n=5 Participants	125 Participants n=4 Participants	156 Participants n=21 Participants	531 Participants n=8 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants	61 Participants n=4 Participants	88 Participants n=21 Participants	275 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=98 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity White Blood Cell Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Platelets Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Bilirubin Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Lymphocyte toxicity	0.0 percentage of participants	0.0 percentage of participants	2.7 percentage of participants	3.2 percentage of participants	0.4 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Hemoglobin Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Absolute Neutrophil Count Toxicity	0.0 percentage of participants	2.2 percentage of participants	0.5 percentage of participants	0.0 percentage of participants	0.4 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity Alanine Transaminase Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity AsparateTransaminase Toxicity	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 120

Population: Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number analyzed" are those who were evaluable at specified category.

Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=73 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=62 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=137 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=144 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=187 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 Lymphocyte Count	0.3 10^9 cells per liter Standard Deviation 0.4	0.3 10^9 cells per liter Standard Deviation 0.4	0.0 10^9 cells per liter Standard Deviation 0.4	0.0 10^9 cells per liter Standard Deviation 0.5	-0.6 10^9 cells per liter Standard Deviation 0.6
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 Platelet	-7.7 10^9 cells per liter Standard Deviation 26.2	-11.9 10^9 cells per liter Standard Deviation 35.3	-20.6 10^9 cells per liter Standard Deviation 37.9	-9.7 10^9 cells per liter Standard Deviation 51.2	-34.0 10^9 cells per liter Standard Deviation 37.2
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 Leukocytes	0.8 10^9 cells per liter Standard Deviation 1.5	0.5 10^9 cells per liter Standard Deviation 1.2	-0.2 10^9 cells per liter Standard Deviation 1.5	-0.1 10^9 cells per liter Standard Deviation 1.4	-0.9 10^9 cells per liter Standard Deviation 1.7
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 Neutrophils	0.4 10^9 cells per liter Standard Deviation 1.3	0.1 10^9 cells per liter Standard Deviation 1.2	-0.2 10^9 cells per liter Standard Deviation 1.4	-0.2 10^9 cells per liter Standard Deviation 1.3	-0.3 10^9 cells per liter Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline, Week 120

Mean change from baseline in hemoglobin at Week 120 was reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=73 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=62 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=137 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=144 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=187 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Change From Baseline in Hemoglobin at Week 120	0.2 grams per deciliter (g/dL) Standard Deviation 0.9	0.2 grams per deciliter (g/dL) Standard Deviation 0.7	-0.1 grams per deciliter (g/dL) Standard Deviation 0.9	0.1 grams per deciliter (g/dL) Standard Deviation 0.9	-0.1 grams per deciliter (g/dL) Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline, Week 120

Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=72 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=62 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=137 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=142 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=185 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120 Aspartate Aminotransferase	0.7 Units per litre (U/L) Standard Deviation 10.6	-1.1 Units per litre (U/L) Standard Deviation 6.4	2.2 Units per litre (U/L) Standard Deviation 7.3	0.7 Units per litre (U/L) Standard Deviation 11.3	0.5 Units per litre (U/L) Standard Deviation 5.1
Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120 Alanine Aminotransferase	2.2 Units per litre (U/L) Standard Deviation 26.0	-1.0 Units per litre (U/L) Standard Deviation 11.7	4.3 Units per litre (U/L) Standard Deviation 14.3	0.7 Units per litre (U/L) Standard Deviation 17.5	1.4 Units per litre (U/L) Standard Deviation 12.2

PRIMARY outcome

Timeframe: Baseline, Week 120

Mean Change From Baseline in Bilirubin at week 120 was reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=73 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=62 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=137 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=144 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=186 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Change From Baseline in Bilirubin at Week 120	0.1 micromoles per liter (mcmol/L) Standard Deviation 3.7	0.0 micromoles per liter (mcmol/L) Standard Deviation 3.5	-0.8 micromoles per liter (mcmol/L) Standard Deviation 3.7	-0.8 micromoles per liter (mcmol/L) Standard Deviation 3.3	-0.4 micromoles per liter (mcmol/L) Standard Deviation 3.7

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.

An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious AE (SAE): Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=98 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	74 Participants	71 Participants	149 Participants	149 Participants	194 Participants
Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	16 Participants	8 Participants	25 Participants	23 Participants	22 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.

An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=22 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=17 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=22 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	16 Participants	13 Participants	18 Participants	—	—
SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	2 Participants	1 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.

Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection are reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=98 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Infections related adverse event	49 Participants	45 Participants	92 Participants	88 Participants	112 Participants
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Herpes viral infection	6 Participants	4 Participants	6 Participants	13 Participants	11 Participants
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Opportunistic infection	8 Participants	4 Participants	9 Participants	17 Participants	15 Participants
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Viral infectious disorder	20 Participants	16 Participants	28 Participants	41 Participants	39 Participants
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Malignancies	2 Participants	1 Participants	7 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 120

Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection were reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=22 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=17 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=22 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Herpes viral infection	0 Participants	1 Participants	1 Participants	—	—
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Opportunistic infection	0 Participants	1 Participants	2 Participants	—	—
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Viral infectious disorder	6 Participants	5 Participants	3 Participants	—	—
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Infections related adverse event	11 Participants	6 Participants	12 Participants	—	—
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies Malignancies	2 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number Analyzed"signifies those participants who were evaluable for specified category.

Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. Time to first CTCAE Grade 3 or 4 hematological or liver toxicity was analyzed by treatment group using Kaplan-Meier plots of probability of surviving toxicity-free and point estimates of percentiles. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th, 20th, 25th, 50th and 75th percentiles were estimated from Kaplan-Meier survival curve.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=5 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=6 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=76 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=99 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=61 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: Hemoglobin	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: WBC	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: ANC	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: WBC	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: WBC	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: WBC	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: WBC	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: ANC	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: ANC	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: ANC	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: ANC	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: Platelets	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: Platelets	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: Platelets	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: Platelets	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: Platelets	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: ALT	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: ALT	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: ALT	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: ALT	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: ALT	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: AST	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: AST	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: AST	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: AST	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: AST	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: Lymphocytes Count	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	14 Days Interval 8.0 to 34.0	8 Days Interval 8.0 to 12.0	362 Days Interval 85.0 to 378.0
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: Lymphocytes Count	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	58 Days Interval 34.0 to 162.0	15 Days Interval 12.0 to 50.0	412 Days Interval 379.0 to 583.0
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: Lymphocytes Count	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	108 Days Interval 57.0 to 379.0	34 Days Interval 15.0 to 57.0	583 Days Interval 406.0 to Due to higher percentiles not attained, upper limit of 95% Confidence Interval from the Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: Lymphocytes Count	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	449 Days Interval 361.0 to Due to higher percentiles not attained, upper limit of 95% Confidence Interval from the Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 75th percentile: Lymphocytes Count	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 10th percentile: Hemoglobin	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 20th percentile: Hemoglobin	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 25th percentile: Hemoglobin	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity 50th percentile: Hemoglobin	—	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.	NA Days Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.

PRIMARY outcome

Timeframe: Baseline up to Week 120

Population: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number Analyzed signifies those participants who were evaluable for specified category.

Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=5 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=4 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=69 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=89 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=50 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Hemoglobin	—	99.0 Days Interval 99.0 to 99.0	64.0 Days Interval 64.0 to 64.0	57.0 Days Interval 57.0 to 57.0	173.5 Days Interval 22.0 to 325.0
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity White Blood Cell Count	—	29.0 Days Interval 29.0 to 29.0	30.0 Days Interval 19.0 to 295.0	42.5 Days Interval 19.0 to 715.0	79.0 Days Interval 28.0 to 125.0
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Absolute Neutrophil Count	43.0 Days Interval 13.0 to 91.0	57.0 Days Interval 29.0 to 85.0	23.8 Days Interval 8.0 to 85.0	34.0 Days Interval 19.0 to 127.0	37.5 Days Interval 15.0 to 162.0
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Lymphocyte	22.0 Days Interval 14.0 to 85.0	31.5 Days Interval 26.0 to 51.0	212.0 Days Interval 8.0 to 1184.0	168.0 Days Interval 7.0 to 799.0	111.3 Days Interval 5.0 to 701.0
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Platelets	—	—	—	197.0 Days Interval 197.0 to 197.0	—
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Alanine Transaminase (ALT)	72.5 Days Interval 51.0 to 94.0	—	—	73.0 Days Interval 19.0 to 127.0	15.0 Days Interval 1.0 to 55.0
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity Aspartate Transaminase (AST)	72.5 Days Interval 51.0 to 94.0	—	84.0 Days Interval 84.0 to 84.0	18.0 Days Interval 18.0 to 18.0	55.0 Days Interval 55.0 to 55.0

PRIMARY outcome

Timeframe: Baseline up to Week 120

Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST) and Platelets. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=5 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=4 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=69 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=89 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=50 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Lymphocyte	41.0 Days Standard Deviation 33.5	34.9 Days Standard Deviation 11.7	256.7 Days Standard Deviation 239.7	241.8 Days Standard Deviation 216.1	160.2 Days Standard Deviation 160.4
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Hemoglobin	—	99.0 Days	64.0 Days	57.0 Days	173.5 Days Standard Deviation 214.3
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity White Blood Cell Count	—	29.0 Days	79.3 Days Standard Deviation 91.9	132.0 Days Standard Deviation 213.9	71.5 Days Standard Deviation 39.7
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Absolute Neutrophil Count	49.0 Days Standard Deviation 39.3	57.0 Days Standard Deviation 39.6	35.3 Days Standard Deviation 29.9	46.8 Days Standard Deviation 35.1	61.0 Days Standard Deviation 55.3
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Platelets	—	—	—	197.0 Days	—
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Alanine Transaminase	72.5 Days Standard Deviation 30.4	—	—	73.0 Days Standard Deviation 76.4	23.7 Days Standard Deviation 28.0
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity Aspartate Transaminase	72.5 Days Standard Deviation 30.4	—	84.0 Days	18.0 Days	55.0 Days

PRIMARY outcome

Timeframe: Baseline up to Week 120

Median time to nadir of absolute lymphocyte count was reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=54 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=57 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=177 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=175 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=227 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Median Time to Nadir of Absolute Lymphocyte Count	162.0 Days Interval 86.0 to 372.0	93.0 Days Interval 37.0 to 252.0	365.0 Days Interval 246.0 to 379.0	162.0 Days Interval 106.0 to 359.0	380.0 Days Interval 379.0 to 400.0

PRIMARY outcome

Timeframe: Baseline up to Week 120

Mean time to nadir of absolute lymphocyte count was reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=54 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=57 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=177 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=175 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=227 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count	292.0 Days Standard Deviation 296.7	193.6 Days Standard Deviation 219.1	276.7 Days Standard Deviation 191.7	241.1 Days Standard Deviation 200.3	362.9 Days Standard Deviation 177.5

PRIMARY outcome

Timeframe: Baseline up to Week 120

Mean time to recovery from nadir of absolute lymphocyte count to normal was reported. Recovery from Nadir is defined as a return to baseline value. Normal absolute lymphocyte count is 1.02 x 10\^3 cells/microliter.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=47 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=52 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=130 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=128 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=185 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value	79.0 Days Standard Deviation 72.4	72.7 Days Standard Deviation 61.3	237.5 Days Standard Deviation 214.7	245.3 Days Standard Deviation 222.3	187.8 Days Standard Deviation 180.9

PRIMARY outcome

Timeframe: Baseline, Week 5, 48, 52 and 96

Population: Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and and "Number analyzed" are those who were evaluable at specified category.

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Mean change in corrected QT (QTc) interval from baseline was reported.

Outcome measures

Outcome measures
Measure	Cladribine Low/Placebo (LLPP) n=25 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=18 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=31 Participants Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=35 Participants Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=41 Participants Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline Week 5	7.0 milliseconds Standard Deviation 21.6	7.4 milliseconds Standard Deviation 21.2	4.5 milliseconds Standard Deviation 20.6	4.3 milliseconds Standard Deviation 16.2	0.7 milliseconds Standard Deviation 18.8
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline Week 48	16.9 milliseconds Standard Deviation 18.6	7.4 milliseconds Standard Deviation 23.6	9.3 milliseconds Standard Deviation 19.8	11.3 milliseconds Standard Deviation 19.5	7.2 milliseconds Standard Deviation 19.6
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline Week 52	14.9 milliseconds Standard Deviation 17.5	22.3 milliseconds Standard Deviation 25.4	8.4 milliseconds Standard Deviation 22.8	5.2 milliseconds Standard Deviation 18.8	-1.2 milliseconds Standard Deviation 16.6
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline Week 96	5.8 milliseconds Standard Deviation 25.5	-4.5 milliseconds Standard Deviation 32.5	-12.5 milliseconds Standard Deviation 22.2	1.6 milliseconds Standard Deviation 22.7	-6.2 milliseconds Standard Deviation 19.2

Adverse Events

Cladribine Low/Placebo (LLPP)

Serious events: 16 serious events

Other events: 73 other events

Deaths: 2 deaths

Cladribine High Dose/Placebo (HLPP)

Serious events: 8 serious events

Other events: 69 other events

Deaths: 0 deaths

Cladribine Low/Low Dose (LLLL)

Serious events: 25 serious events

Other events: 143 other events

Deaths: 1 deaths

Cladribine High/Low Dose (HLLL)

Serious events: 23 serious events

Other events: 146 other events

Deaths: 0 deaths

Placebo/Cladribine Low Dose (PPLL)

Serious events: 22 serious events

Other events: 192 other events

Deaths: 0 deaths

Placebo/No Treatment

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Cladribine 3.5 mg/kg/No Treatment

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Cladribine 5.25 mg/kg/No Treatment

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cladribine Low/Placebo (LLPP) n=98 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 participants at risk Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/No Treatment n=22 participants at risk Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 3.5 mg/kg/No Treatment n=17 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 5.25 mg/kg/No Treatment n=22 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 2/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 2/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 2/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast fibroma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Juvenile melanoma benign	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Herpes zoster	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 2/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Pneumonia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.2% 3/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Urinary tract infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.82% 2/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Abscess oral	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Appendicitis	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Bacterial sepsis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Breast abscess	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Gastroenteritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Infection	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Influenza	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Pulmonary tuberculosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Pyelonephritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Pyelonephritis chronic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Urethral abscess	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Colonic polyp	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Duodenal ulcer	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gastric haemorrhage	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gastritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Ileus paralytic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Peritonitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Limb injury	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Reproductive system and breast disorders Menorrhagia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Cardiac disorders Myocardial infarction	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Cardiac disorders Tachycardia	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Chest pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Death	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Drowning	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Influenza like illness	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Hepatobiliary disorders Cholelithiasis	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 2/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Hepatobiliary disorders Cholecystitis	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Hepatobiliary disorders Biliary colic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood culture positive	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Pregnancy test positive	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Tuberculin test positive	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Weight decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Brain injury	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Cauda equina syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Radicular syndrome	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Sciatica	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Status epilepticus	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Asthma	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Mental disorder	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Suicidal ideation	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Suicide attempt	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Endocrine disorders Basedow's disease	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Endocrine disorders Thyroiditis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Eye disorders Iridocyclitis	2.0% 2/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Eye disorders Macular degeneration	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Cystitis noninfective	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Renal failure acute	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Renal failure chronic	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Vascular disorders Varicose vein	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Ear and labyrinth disorders Vertigo positional	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Immune system disorders Secondary immunodeficiency	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.41% 1/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Surgical and medical procedures Abortion induced	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Crohn's disease	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Vascular disorders Venous Stasis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Stage 0	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Lymphadenopathy	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Acarodermatitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.

Other adverse events

Other adverse events
Measure	Cladribine Low/Placebo (LLPP) n=98 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).	Cladribine High Dose/Placebo (HLPP) n=92 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine Low/Low Dose (LLLL) n=186 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Cladribine High/Low Dose (HLLL) n=186 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/Cladribine Low Dose (PPLL) n=244 participants at risk Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.	Placebo/No Treatment n=22 participants at risk Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 3.5 mg/kg/No Treatment n=17 participants at risk Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).	Cladribine 5.25 mg/kg/No Treatment n=22 participants at risk Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Gastrointestinal disorders Diarrhoea	7.1% 7/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	6.5% 6/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.2% 6/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.8% 9/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.7% 14/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Lymphopenia	9.2% 9/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.6% 7/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	36.6% 68/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	40.3% 75/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	28.3% 69/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 2/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	22.7% 5/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Leukopenia	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 2/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	10.2% 19/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	10.8% 20/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.9% 12/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	13.6% 3/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Neutropenia	2.0% 2/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 2/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.8% 7/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 10/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.9% 7/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	20.0% 1/5 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	22.7% 5/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Ear and labyrinth disorders Vertigo	5.1% 5/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.2% 6/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.0% 5/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Nausea	8.2% 8/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.3% 4/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 11/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.8% 7/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.1% 10/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Toothache	4.1% 4/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	6.5% 6/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.6% 3/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.6% 4/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	13.6% 3/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Vomiting	1.0% 1/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 5/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.6% 4/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Fatigue	5.1% 5/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 5/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.3% 8/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 10/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.9% 12/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 2/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Influenza like illness	5.1% 5/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 2/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.5% 14/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.8% 9/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.1% 10/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 2/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Nasopharyngitis	19.4% 19/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	16.3% 15/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 22/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	15.1% 28/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	18.4% 45/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	27.3% 6/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Influenza	11.2% 11/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	10.9% 10/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	8.1% 15/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	12.4% 23/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.0% 17/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	18.2% 4/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 2/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Upper respiratory tract infection	8.2% 8/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.8% 9/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 17/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	10.8% 20/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.8% 19/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Urinary tract infection	6.1% 6/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.3% 4/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 17/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	8.6% 16/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	6.6% 16/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Back pain	9.2% 9/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.8% 9/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	8.6% 16/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.7% 18/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.5% 28/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	23.5% 4/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	8.2% 8/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	6.5% 6/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 10/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 10/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 11/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 5/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.3% 4/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.3% 8/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.3% 13/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	13.6% 3/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Headache	20.4% 20/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	17.4% 16/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.3% 21/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	13.4% 25/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	15.6% 38/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	13.6% 3/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	18.2% 4/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Depression	6.1% 6/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 1/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.2% 6/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	3.7% 9/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Anxiety	5.1% 5/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 2/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.2% 4/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.9% 7/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Vascular disorders Hypertension	4.1% 4/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.4% 5/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.7% 5/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	1.1% 2/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	2.9% 7/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Bronchitis	6.1% 6/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.6% 7/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.54% 1/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	6.5% 12/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	7.0% 17/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Anaemia of pregnancy	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Ear and labyrinth disorders Ear pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Eye disorders Eye irritation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Eye disorders Eye pruritus	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Tooth disorder	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Faecal incontinence	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Asthenia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Hyperthermia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	11.8% 2/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Immune system disorders Hypersensitivity	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Respiratory tract infection viral	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Pneumonia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Sinusitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Viral infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Erythema infectiosum	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Herpes zoster	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Infected insect bite	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Injection site abscess	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Skin bacterial infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations White blood cell count decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Alanine aminotransferase increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Red blood cell burr cells present	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Liver function test abnormal	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Weight decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Dizziness	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Restless legs syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Syncope	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Depressed mood	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	9.1% 2/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	5.9% 1/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Abscess Limb	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Acute Tonsillitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Anisocytosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Aphthous Stomatitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Aspartate Aminotransferase Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood Potassium Decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood Urea Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Blood Urine Present	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Cyst	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Reproductive system and breast disorders Breast Discharge	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Breath Sounds Abnormal	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Bundle Branch Block Left	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Cervical Dysplasia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Chest Pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Dysuria	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Eosinophil Count Decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Eosinophil Count Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Psychiatric disorders Excoriation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Facial Pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Furuncle	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gastroenteritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Gingivitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Haemoglobin Decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Metabolism and nutrition disorders Haemorrhoids	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Hemicephalalgia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Hordeolum	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Vascular disorders Hot Flush	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Congenital, familial and genetic disorders Hyperbilirubinaemia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Injection Site Erythema	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Injection Site Extravasation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Injection Site Inflammation	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Injection Site Pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Local Swelling	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Immune system disorders Lower Respiratory Tract Infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Macrocytosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Monocyte Count Decreased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal Disorder	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Neuralgia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Oedema Peripheral	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Oesophagitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Gastrointestinal disorders Oral Candidiasis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Oral Herpes	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cyst	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Paraesthesia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Paronychia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Patellofemoral Pain Syndrome	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Poikilocytosis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Protein Urine Present	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Renal and urinary disorders Proteinuria	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
General disorders Pyrexia	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Blood and lymphatic system disorders Red Blood Cell Abnormality	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Red Blood Cell Morphology Abnormal	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Respiratory Tract Infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Eye disorders Retinal Tear	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Smear Cervix Abnormal	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Injury, poisoning and procedural complications Tendonitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Tension Headache	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Thyroid Function Test Abnormal	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Respiratory, thoracic and mediastinal disorders Tonsillitis	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Tooth Abscess	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Tooth Infection	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Tremor	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Infections and infestations Urinary Tract Infection Bacterial	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Nervous system disorders Vertigo Positional	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations Weight Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Investigations White Blood Cell Count Increased	0.00% 0/98 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/92 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/186 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/244 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	0.00% 0/17 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.	4.5% 1/22 • Baseline up to Week 120 For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER