Trial Outcomes & Findings for Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections (NCT NCT00466817)

NCT ID: NCT00466817

Last Updated: 2015-08-26

Results Overview

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 109 participants
• Primary outcome timeframe: Between baseline and 6 months
• Results posted on: 2015-08-26

Participant Flow

All 109 subjects started on valganciclovir. At the end of 6 weeks, subjects were randomized to valganciclovir or placebo. of the 109 subject that started, 12 dropped out before randomization and 1 subject was randomized but never received any blinded study drug.

Participant milestones

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Overall Study STARTED	49	47
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

Baseline characteristics by cohort

Measure	Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo n=49 Participants Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=47 Participants Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.	Total n=96 Participants Total of all reporting groups
Age, Continuous	19 weeks n=5 Participants	14 weeks n=7 Participants	15 weeks n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	47 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: Between baseline and 6 months

Population: Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=43 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=43 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Change in Best Ear Hearing Assessments at 6 Months. Worsened	3 participants	5 participants
Change in Best Ear Hearing Assessments at 6 Months. No Change	37 participants	36 participants
Change in Best Ear Hearing Assessments at 6 Months. One point improvement	3 participants	2 participants

SECONDARY outcome

Timeframe: baseline through 7 months

Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=49 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=47 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. Permanent discontinuation of study drug	0 participants	0 participants
Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event. Irreversible outcome from use of study drug	0 participants	0 participants

SECONDARY outcome

Timeframe: Between baseline and 12 months

Population: Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Change in Best Ear Hearing Assessments at 12 Months. Improved hearing	2 participants	2 participants
Change in Best Ear Hearing Assessments at 12 Months. No change - same degree of hearing loss	10 participants	6 participants
Change in Best Ear Hearing Assessments at 12 Months. No change - normal hearing	23 participants	30 participants
Change in Best Ear Hearing Assessments at 12 Months. Worsening hearing	5 participants	3 participants

SECONDARY outcome

Timeframe: Between baseline and 24 months

Population: Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=31 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=37 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Change in Best Ear Hearing Assessments at 24 Months. Improved hearing	2 participants	2 participants
Change in Best Ear Hearing Assessments at 24 Months. No change - normal hearing	20 participants	30 participants
Change in Best Ear Hearing Assessments at 24 Months. No change - same degree of hearing loss	7 participants	2 participants
Change in Best Ear Hearing Assessments at 24 Months. Worsening hearing	2 participants	3 participants

SECONDARY outcome

Timeframe: Between baseline and 6 months

Population: Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=43 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=43 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects) Improved or protected hearing	46 ears	52 ears
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects) Same hearing loss or deterioration	38 ears	30 ears

SECONDARY outcome

Timeframe: Between baseline and 12 months

Population: Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects) Improved or protected hearing	44 ears	58 ears
Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects) Same hearing loss or worsening	33 ears	21 ears

SECONDARY outcome

Timeframe: Between baseline and 24 months

Population: Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=31 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=37 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects) Improved or protected	37 ears	54 ears
Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects) Same hearing loss or worsened hearing	21 ears	16 ears

SECONDARY outcome

Timeframe: Between baseline and 6 months

Population: Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=43 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=43 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects) No worsening of hearing	75 ears	71 ears
Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects) Worsening hearing	9 ears	11 ears

SECONDARY outcome

Timeframe: Between baseline and 12 months

Population: Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects) No worsening of hearing	67 ears	73 ears
Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects) Worsening hearing	10 ears	6 ears

SECONDARY outcome

Timeframe: Between baseline and 24 months

Population: Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.

Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. Following this, the study audiologist assigned the "best ear" classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification was mild hearing loss.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=31 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=37 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects) No worsening of hearing	53 ears	62 ears
Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects) Worsening hearing	5 ears	8 ears

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed

Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=45 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=43 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).	76.5 units on a scale Standard Error 3.4	84.2 units on a scale Standard Error 3.0

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed

Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=43 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).	5.8 units on a scale Standard Error 0.5	6.8 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed

Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=44 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).	6.1 units on a scale Standard Error 0.5	7.3 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed

Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=43 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).	74.8 units on a scale Standard Error 3.2	82.9 units on a scale Standard Error 2.9

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed

Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=44 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).	5.5 units on a scale Standard Error 0.6	6.5 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed

Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=44 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=42 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).	4.9 units on a scale Standard Error 0.6	5.6 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 12 Months after enrollment

Population: only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed

Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=44 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=42 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).	70.0 units on a scale Standard Error 3.7	76.5 units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: 24 Months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed

Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=41 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).	4.9 units on a scale Standard Error 0.5	6.4 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 24 months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed

Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=41 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=42 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).	74.9 units on a scale Standard Error 2.8	79.6 units on a scale Standard Error 2.9

SECONDARY outcome

Timeframe: 24 Months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed

Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=41 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).	5.3 units on a scale Standard Error 0.6	6.5 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 24 Months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed

Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=41 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).	71.2 units on a scale Standard Error 3.3	79.5 units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: 24 Months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed

Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=42 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).	6.0 units on a scale Standard Error 0.7	6.9 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 24 Months after enrollment.

Population: only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed

Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=42 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).	4.9 units on a scale Standard Error 0.6	6.1 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 24 Months after enrollment

Population: only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed

Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.

Outcome measures

Measure	Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo n=40 Participants Six weeks of oral Valganciclovir followed by placebo to complete the six month time period. Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.	Valganciclovir: 24 Wks of Valganciclovir n=41 Participants Six months of oral Valganciclovir. Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.
Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).	71.8 units on a scale Standard Error 3.7	80.1 units on a scale Standard Error 3.3

Adverse Events

Non Randomized

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Active

Serious events: 11 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo After 6 Weeks of Valganciclovir

Serious events: 19 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Non Randomized n=13 participants at risk 6 weeks of open label valganciclovir only	Active n=47 participants at risk 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir	Placebo After 6 Weeks of Valganciclovir n=49 participants at risk 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	16.3% 8/49 • Number of events 9 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Vomoting	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Pyrexia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Bronchiolitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Gastroenteritis viral	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Otitis medial	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Pneumonia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory tract infection viral	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Urinary tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Injury, poisoning and procedural complications Head injury	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Feeding disorder neonatal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Respiratory distress	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.

Other adverse events

Measure	Non Randomized n=13 participants at risk 6 weeks of open label valganciclovir only	Active n=47 participants at risk 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir	Placebo After 6 Weeks of Valganciclovir n=49 participants at risk 6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
Injury, poisoning and procedural complications Feeding tube complication	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Nasopharyngitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Oral candidiasis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	14.9% 7/47 • Number of events 9 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	12.2% 6/49 • Number of events 6 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Oral fungal infection	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Otitis media	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	23.4% 11/47 • Number of events 15 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	24.5% 12/49 • Number of events 23 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Otitis media acute	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Otitis media bacterial	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Pneumonia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Recurring skin boils	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations White blood cell count decreased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations White blood cell count increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Respiratory tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Rhinitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Sinusitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Skin candida	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	31.9% 15/47 • Number of events 24 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	28.6% 14/49 • Number of events 19 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Urinary tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Viral infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Viral rash	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Injury, poisoning and procedural complications Scratch	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Alanine aminotransferase increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Bacteria stool identified	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Blood bilirubin increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Blood calcium increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Blood potassium increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Body temperature increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Carbon dioxide decreased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Cardiac murmur	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Eosinophil count increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Haemoglobin abnormal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Haemoglobin decreased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Head lag	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Liver function test abnormal	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	12.8% 6/47 • Number of events 6 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 7 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Neutrophil count abnormal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Neutrophil count decreased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Nuclear magnetic resonance imaging abnormal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Occult blood positive	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Stool analysis abnormal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Transaminases increased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Investigations Weight decreased	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Neutropenia Neonatal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Anaemia	15.4% 2/13 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.6% 5/47 • Number of events 6 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	18.4% 9/49 • Number of events 13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	23.4% 11/47 • Number of events 15 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	28.6% 14/49 • Number of events 33 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Red blood cell abnormality	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Cardiac disorders Cyanosis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Ear and labyrinth disorders Hearing impaired	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Ear and labyrinth disorders Otorrhoea	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Endocrine disorders Hypothyroidism	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Astigmatism	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Blindness	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Conjunctival irritation	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Conjunctivitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.5% 4/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Dacryostenosis acquired	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Eye discharge	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Eye movement disorder	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Lacrimal disorder	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Photalgia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Strabismus	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Eye disorders Swollen tear duct	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Anal fistula	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Constipation	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	14.9% 7/47 • Number of events 8 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	19.1% 9/47 • Number of events 9 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	26.5% 13/49 • Number of events 23 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Dysphagia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Enteritis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Flatulence	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.6% 5/47 • Number of events 6 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	16.3% 8/49 • Number of events 8 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.6% 5/47 • Number of events 6 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	20.4% 10/49 • Number of events 11 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Gingival pain	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Infantile colic	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.6% 5/47 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Infantile spitting up	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Melaena	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Mouth ulceration	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Oral pain	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Reflux gastritis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Umbilical hernia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	19.1% 9/47 • Number of events 14 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	12.2% 6/49 • Number of events 12 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Developmental delay	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Discomfort	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Feeling jittery	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Fever neonatal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Irritability	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Irritability postvaccinal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
General disorders Pyrexia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	16.3% 8/49 • Number of events 10 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Hepatobiliary disorders Cholestasis	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Hepatobiliary disorders Hepatomegaly	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Immune system disorders Anaphylactic reaction	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Immune system disorders Milk allergy	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Adenoviral upper respiratory infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Bronchiolitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Candida nappy rash	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Bronchitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Candidiasis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Cellulitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Croup infectious	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Ear infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Gastroenteritis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.6% 5/47 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Gastroenteritis viral	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Genital candidiasis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Infections and infestations Lower respiratory tract infection	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Reflexes abnormal	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Sleep phase rhythm disturbance	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Renal and urinary disorders Hydronephrosis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Reproductive system and breast disorders Genital erythema	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Reproductive system and breast disorders Penile pain	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Allergic respiratory disease	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Allergic respiratory symptom	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	14.9% 7/47 • Number of events 8 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	10.2% 5/49 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.5% 4/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	12.2% 6/49 • Number of events 8 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Nasopharyngeal reflux	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Acne	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Acne infantile	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	23.4% 11/47 • Number of events 11 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 5 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Eczema infantile	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Erythema toxicum neonatorum	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	12.8% 6/47 • Number of events 7 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	22.4% 11/49 • Number of events 13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.4% 3/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Surgical and medical procedures Circumcision	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Surgical and medical procedures Oxygen supplementation	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Hypotonia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.1% 2/49 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Fluid intake reduced	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	4.3% 2/47 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Musculoskeletal and connective tissue disorders Head deformity	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Musculoskeletal and connective tissue disorders Ligament laxity	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Musculoskeletal and connective tissue disorders Loose body in joint	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Convulsion	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Crying	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Dystonia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/47 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Hypersomnia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Hypertonia	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.5% 4/47 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	8.2% 4/49 • Number of events 4 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Infantile spasms	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Muscle spasticity	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.0% 1/49 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Partial seizures	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 2 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	6.1% 3/49 • Number of events 3 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.
Nervous system disorders Poor quality sleep	0.00% 0/13 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	2.1% 1/47 • Number of events 1 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.	0.00% 0/49 • Adverse events were reported between baseline and 7 months There were three groups: 13 subjects who only received 6 weeks of open label valganciclovir (these 13 did not receive blinded study drug)); 47 subjects receive a full 24 weeks of valganciclovir and 49 subjects received 6 weeks of valganciclovir and 18 weeks of placebo.

Additional Information

David Kimberlin, MD

University of Alabama in Birmingham

Phone: 205-934-2424

Email: dkimberlin@peds.uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60