Overnight Pant Safety-in-use Diary Clinical Trial for Children With Nocturnal Enuresis
Phase: NA
Conditions: Nocturnal Enuresis
Sponsor: Procter and Gamble

 
 
 
 
   Cover page 
 
  
 
 
 
 
 
 
 
Non-ACT Voluntary Submission 
                                         
                   This document contains the following IRB Approved documents: 
 
                           Study Protocol & Statistical Plan (Date: Nov 29, 2021) 
                                  Protocol Amendment #1 (Dated: 13 Dec, 2021) 
 
 
             For study: 
 
 
OVERNIGHT PANT SAFETY-IN-USE DIARY CLINICAL TRIAL 
FOR CHILDREN WITH NOCTURNAL ENURESIS 
CSD2021096/ NCCI #12-2103 
Date: Nov 29, 2021 
NCT# 05178641 
 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       i 
OVERNIGHT PANT SAFETY-IN-USE DIARY CLINICAL TRIAL 
FOR CHILDREN WITH NOCTURNAL ENURESIS 
CSD2021096/ NCCI #12-2103 
Date: Nov 29, 2021 
Principal Investigator:  
Laura Huesing-Wray 
North Cliff Consultants  
6831 Colerain Ave 
Cincinnati Ohio, United States 
Phone: +1 (513) 728 2595 
 
Sub-Investigators:  
Anita Sheth, M.D. (Ped. Dermatologist 
North Cliff Consultants  
6831 Colerain Ave 
Cincinnati Ohio, United States 
Phone: +1 (513) 245-2800 
 
Mona Choueiry, M.D. (Pediatricia 
North Cliff Consultants  
6831 Colerain Ave 
Cincinnati Ohio, United States 
Phone: +1 (513) 245-2800 
 
Sponsor:  
The Procter & Gamble Company  
Winton Hill Business Center 
6280 Center Hill Ave. 
Cincinnati, OH  45224 
 
Clinical Scientist:  
Susanna Brink, Ph.D. 
Phone: +49 (0) 6196 89 4474 
 
Clinical Trial Manager:  
Jasmin Kraemer 
Phone: +49 (0) 6196 89 1733 
 
Statistician:  
Yu Wang 
Phone: (513) 622-3894 
 
Clinical Data Manager:  
Yu Lisa Bowman 
Phone: (513) 634-1738 
 
Regulatory:  
Yu Johanna Albrecht 
Email: Albrecht.j@pg.com 
 
Toxicologist:  
Yu Tingting Zhu, Ph.D. 
Phone: +86 (0) 180452508 
 
BFF Clinical Director   
Yu Ann Lawrence, Ph.D. 
Phone: (513) 240-2153 
  
 
Clinical Trial Location:  
North Cliff Consultants  
6831 Colerain Ave 
Cincinnati, Ohio, United States 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       ii 
Sponsor's Representatives Signatures 
This protocol has been approved by the Sponsor and Sponsor’s Representatives of the clinical 
trial.  
 
 
 
 
 
 
Yu Ann Lawrence, Ph.D. 
Date 
BFF Clinical Director 
 
 
 
 
 
 
Susanna Brink, Ph.D. 
Date 
Clinical Scientist 
 
 
 
 
 
 
Yu Jasmin Kraemer 
Date 
Clinical Trial Manager 
 
 
 
 
 
 
Yu Johanna Albrecht 
Date 
Regulatory 
 
 
 
 
 
 
Yu TingTing Zhu 
Date 
Toxicologist 
 
 
 
 
 
 
Yu Yu Wang 
Statistician 
Date 
 
 
 
 
 
 
Yu Lisa Bowman 
Data Manager 
Date 
 
 
 
 
 
 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       iii 
Investigator’s Signature 
 
Protocol Number: 
 
CSD2021096 
Title of Protocol: 
 
OVERNIGHT PANT SAFETY-IN-USE DIARY CLINICAL TRIAL 
FOR CHILDREN WITH NOCTERNAL ENURESIS 
 
Investigator’s Agreement Statement: 
 
I have read and understand this protocol and concur with the clinical trial design. I agree 
to participate as an Investigator and to follow the protocol as outlined. I will submit a 
written report after completion of the clinical trial. 
 
 
 
Principal Investigator 
 
 
 
 
Laura Huesing-Wray 
 
 
(Date) 
 
Sub-Investigator 
 
 
 
 
Yu Anita Sheth, M.D.  
(Ped. Dermatologist) 
 
 
(Date) 
 
 
Sub-Investigator 
 
 
 
 
Mona Choueiry, M.D. 
(Pediatrician) 
 
(Date) 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       iv 
Table of Contents 
 
Contents 
Sponsor's Representatives Signatures ....................................................................................... ii 
Table of Contents ...................................................................................................................... iv 
 
List of Abbreviations……………………………………………………………………………………..vi 
Clinical Trial Protocol ................................................................................................................ 1 
1. 
Introduction ...................................................................................................................... 1 
2. 
Objectives ........................................................................................................................ 4 
3. 
Investigational Plan ......................................................................................................... 4 
3.1 
Clinical Trial Design .................................................................................................. 4 
3.2 
Clinical Trial Procedures ........................................................................................... 6 
3.3. Selection of Clinical Trial Population ....................................................................... 10 
3.4 
Subject Identification ............................................................................................... 12 
3.5 
Subject Accountability ............................................................................................. 12 
3.6 
Products .................................................................................................................. 13 
3.7 
Assessment and Collection Details ......................................................................... 13 
4. 
Statistical Methods ........................................................................................................ 15 
4.1 
Statistical Analysis .................................................................................................. 15 
4.2 
Determination of Sample Size ................................................................................. 15 
5. 
Risk Assessment- See Attachment A ........................................................................... 15 
6. 
Conduct of the Clinical Trial ......................................................................................... 15 
6.1 
Protocol Amendment(s) .......................................................................................... 15 
7. 
Obligation of the Investigator ....................................................................................... 16 
7.1 
Adherence to Protocol ............................................................................................. 16 
7.2 
Advertising .............................................................................................................. 16 
7.3 
Subject Consent ...................................................................................................... 16 
7.4 
Data Collection ........................................................................................................ 16 
7.5 
Adverse Events or Adverse Device Effects ............................................................. 17 
7.6  Device Deficiency Reporting ................................................................................... 19 
7.7 
Investigator’s Final Report ....................................................................................... 20 
7.8 
Records Retention .................................................................................................. 20 
7.9 
Publications............................................................................................................. 20 
8. 
Sponsor Clinical Trial Management.............................................................................. 20 
8.1 
Data Quality Assurance .......................................................................................... 20 
8.2 
Clinical Trial Termination ......................................................................................... 21 
8.3 
Sponsor’s Final Report ............................................................................................ 21 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       v 
Attachment A – Risk Assessment ........................................................................................... 22 
Attachment B – Staristical Analysis Plan ................................................................................. 24 
 
Protocol Amendment #1……………………………………………………………………………….26 
 
Protocol Amendment #2………………………………………………………………………………29 
 
 
 
 
 
 
 
 
 
 
 
 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                       vi 
List of Abbreviations: 
 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AI 
Adult Incontinence 
CER 
Clinical Evaluation Report  
CRF 
Case Report Form 
eCRF 
Electronic Case Report Form 
GCP 
Good Clinical Practices 
H&P 
Habits and Practices 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
MDR 
Medical Device Regulation 
ISO 14155 Clinical Investigation of Medical Devices for Human subjects GCPs 
ISO 14971 Medical Devices - Application of Risk Management to Medical Devices 
NJ EU 
Ninjamas Europe Overnight Pant 
NJ US 
Ninjamas US Overnight Pant 
pH 
Potential Hydrogen 
P&G 
Procter & Gamble 
QoL 
Quality of Life 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SCH 
Stratum Corneum Hydration 
TEWL 
Trans Epidermal Water Loss 
TMF 
Trial Master File 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               1 
Clinical Trial Protocol 
1. Introduction 
Ninjamas Europe (NJ EU) is an absorbent disposable single-use underwear pant developed for 
children suffering from nocturnal enuresis (nighttime bedwetting). The NJ EU absorbent 
underwear pant helps manage and contain urination gushes at night for up to 12 hours. It is not 
intended to treat or cure nocturnal enuresis. It is a non-invasive device and intended for external 
application on intact skin. It is a simple non-active device (without electronics or batteries) that is 
very easy to use. No specific training is required to use this product. It is available in 2 sizes: 
Size 7 for children aged 4-7 (17-29 kg) and Size 8 for children aged 8-12 years (27-43kg). 
Since nocturnal enuresis in the age group 5 years and above is considered a medical condition 
in Europe, this absorbent underwear pant is regulated as a Class 1 medical device in the EU. 
This clinical trial will be part of the body of clinical evidence needed to support the Medical 
Device Report, which is required to market this absorbent product as a nocturnal enuresis 
management tool for children age 4-12 years in the EU.    
 
There are several ways to manage nocturnal enuresis in children. This clinical trial will focus on 
the first option only: 
 
• 
Absorbent underwear to manage urine loss without treating it.  
• 
Bed mats absorb urine and prevent the mattress from getting wet but do not keep the 
child’s clothing and bed sheets from getting wet.  
• 
Fluid and diet restriction prior to bedtime. 
• 
Waking the child at specific times during the night to go to the bathroom. 
• 
Bladder training or retention control training, where the child is trained to hold the urine 
as long as possible in order to increase bladder capacity.  
• 
Rewards and star charts to encourage nights without bedwetting. 
• 
Wetness alarms (bells or vibrations that wake the child when urinating). 
• 
Desmopressin (synthetic version of anti-diuretic hormone). 
• 
Anticholinergic medicine (e.g., Oxybutynin) reduces the number of involuntary bladder 
contractions and has a relaxant effect on the smooth muscle of the bladder. This 
decreases the urge to pass urine and allows the bladder to hold more urine. 
• 
Tricyclic drugs - work the same as Oxybutynin but are only used in cases where other 
drugs are not working. The need for close follow up and the potential for serious cardiac 
consequences with overdose mean they are considered for use in specialist centers 
only. 
• 
Psychological treatment. 
 
The P&G company has a 20+ year history of baby diaper clinical data (0-36 months) to show that 
our diaper and pant technology is safe to use and effective for managing urine gushes in a baby 
and toddler population. The P&G company also has adult (18+ years) female incontinence 
products in the EU market, including absorbent heavy incontinence pants, that are classified as 
Class 1 Medical Devices, which were demonstrated to be safe to use and effectively manages 
urine gushes of adults as seen in the statement of compliance from the CER report dated Feb 
2020 [1]. Since Aug 2020 the P&G company markets a similar Ninjamas night-time pant product 
in the USA for bedwetting children aged 4-12 years. (Same age group and intended use as NJ EU 
product) and P&G markets a training pant (BabyDry Pants S7) in the EU. Based on the Post Market 
Safety Surveillance data of similar products in the EU und US market (BabyDry Pants, FemCare 
AI Pants, NJ US pants), we have reason to believe that the NJ EU product will have no safety 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               2 
related issues when used as an overnight pant for children aged 4-12 years, based on skin and 
health related AEs. [2]  
 
Although the design of the P&G Adult Incontinence pull-up pants and the pull-up pants for babies 
and toddlers are comparable to that of the NJ EU Pull-up pant for bedwetting children, and there 
is a reason to believe that the NJ EU pull up pant meets all safety and product performance 
requirements, P&G currently has no clinical evidence to support the product safety and efficacy 
for the population of children aged 4-12 years. This clinical trial provides helpful technical data to 
bridge to the existing body of evidence clinical data from adult and baby clinical trials and gather 
clinical safety in-use data for this specific population of children, with a different gush volume than 
adults and babies and using the products only during night.  
 
Looking at the prevalence of nocturnal enuresis, this condition is more likely among younger 
children (size 7, or S7, which is designed for children aged 4-7) than older children (size 8, or S8, 
which is designed for children aged 8-12). The graphs below show data from publications on 
nocturnal enuresis for UK [3] and USA [4] respectively. 
 
Figure 1 & 2: Prevalence of Nocturnal Enuresis for UK [1] and USA [2]. 
 
 
 
This clinical trial will therefore focus on the more representative S7 group. Reasons for choosing 
this group include:  
 
1. 
This group will be easier to recruit with approximately 10-25% of the population 
suffering from nocturnal enuresis at age 4-7, compared to only 1-5% of the 
population at age 8-12. In addition, the willingness of younger children to 
participate in a bedwetting clinical trial where the parent needs to do 
measurements in the pant area will be higher than for older children, who may 
not want the parent in the room when they remove their pant.  
 
2. 
Traditionally children are not considered for treatment of bedwetting until age 7. 
Over the age of 7 the child is usually treated with drug therapy to reduce urine 
production at night. 
 
3. 
The S7 and S8 NJ EU pants have the same design, with S8 having a more 
absorbent capacity and a bigger fit.  
 
4. 
P&G consumer studies (see tables below) show that there is no significant 
difference in nightly urine production comparing children in the S7 group vs. the 
S8 group. This means that the lower capacity S7 pant will be likely to be more 
wet than the S8 pant under the same load conditions. 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               3 
 
Consumer Study 1. Certina Pad/Pant C&SPIT #US01612 (Jul 2001) 
  
 
 
Panelists: 8-12yrs old (Base: 19) 
 
Certina 
Size 1-2 Liners 
Liner 
(PSC2 size5 base) 
Base    (pad) 
36 
8 
Ave. load  (g) 
124 
137 
SD 
36 
72 
 
Consumer Study 2. Ninjya leakage diary #BCRC 6-01-21 (Jun 2001) 
  
 
 
Panelists 
L: 5-9yrs old, 29-39kgf  (Base: 16) 
  
 
 
 
 
 
XL: 9-12yrs old, 36-50kgf  (Base: 5) 
 
Ninjya (Pull-on) 
L-Size 
Ninjya (Pull-on) 
XL-Size 
Base    (pad) 
149 
20 
Ave. load  (g) 
153 
132 
SD 
36 
72 
 
5. 
Younger children are more likely to wait for a parent to assist with dressing and 
will therefore wear the wet pant longer than an older child, who is more likely to 
remove the pant themselves. Younger children also have a higher risk of feces 
on the skin (which is an irritant for the skin) as they are not well-practiced in 
wiping themselves clean after visiting the toilet. Therefore, the S7 group has 
more risk of developing rash from wet pants than the S8 group, because their 
skin is wet longer and any feces resting on the skin can result in compromised 
skin and rash in the pant area.    
 
Our focus will be on children with monosymptomatic enuresis i.e., enuresis in children without any 
other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, 
genital, or lower urinary tract pain) and without a history of bladder dysfunction. 
 
This clinical trial will accept children with both primary and secondary enuresis. Primary enuresis 
means the child has never had a dry period at night. Secondary enuresis means the child 
developed nocturnal enuresis after being dry for a period of at least six months.  
 
This clinical trial will be a 6-week, in-home clinical trial to understand the safety, performance, 
and impact on skin of the NJ EU pant compared to the child’s currently used absorbent pant or 
diaper product. 
 
References: 
1. CER-Adult Incontinence Devices- MDR 2017 745_Updated (Reference: 
QFI/0631/CER/180822/01) Date 22 August 2018 (last amended 18 February 2020)  
2. Post Market Safety Surveillance report from GSSA organization showing data from past 2 
years for BabyDry Pants marketed in EU, FemCare AI pants marketed in EU + USA and 
Ninjama pants marketed in USA.  
3. /https://www.brollysheets.co.uk/blogs/night-training/bed-wetting-statistics-how-common-is-it 
4. Kids Health Information: Bedwetting (rch.org.au) 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               4 
2. Objectives  
The primary objective of this clinical trial is to confirm the in-use tolerability of the Ninjama EU 
overnight pant product, in the target population of bedwetters aged 4-7 years, based on a body 
of evidence from clinical assessments of skin, adverse events and parent/child perception data. 
This data will be part of the clinical evidence in the Clinical Evaluation Report needed to market 
this product as a Class 1 Medical Device in the EU, confirming that the product is safe to use and 
performs within its intended purpose. 
 
The secondary objective is to understand the clinical benefit of the NJ EU overnight pant product 
in a bedwetting population aged 4-7 years, based on quality of life, healthy skin and waking up in 
a dry bed, via collecting H&P and parent/child perception data in diaries and end-of-use 
questionnaires.  
 
The learnings from this clinical trial will be used as supporting data for potential claims. 
 
3. Investigational Plan 
3.1 Clinical Trial Design 
This will be a single center, single blinded (sponsor’s team will be blinded to the product codes), 
randomized, cross-over, IRB-Approved, in-home clinical test design over 6 weeks, with two usage 
periods of 3 weeks each. During one period the child will maintain usage of their usual absorbent 
night pant/diaper and during the other usage period they will use the NJ EU absorbent pant. We 
will track habits and practices that may impact skin health and product performance as well as 
medication use and Adverse Events/ Adverse Device Effects (AEs /ADEs). Children will be asked 
to wear either their own pants or the test pants exclusively at night and parent/legal guardian will 
be asked to collect data in the evening before bed and in the mornings after getting up.   
 
Parent/Legal Guardian will be trained to execute the measurements on their own child for the   
following reasons: 
 
1. Children this age are usually told not to let strangers touch them in the genital and 
buttock area, so we want to avoid telling kids it is OK in this case. We will ensure that the 
child is comfortable to participate in this clinical trial and can at any time end their 
participation in this clinical trial should they feel uncomfortable.  
 
2. Due to COVID restrictions, clinical trial personnel should minimize close contact with 
panelists as much as possible, especially with children under 5 years of age, who cannot 
be vaccinated. We will therefore ask the trained parent/legal guardian to do the 
measurements on his/her own child/ren. Children can stop the study procedures at any 
time if/when they feel uncomfortable.  
This clinical trial is designed to track the following:  
• 
general safety (AEs and ADEs),  
• 
assess skin properties in the pant area (parental assessment of skin wetness, rash, 
pressure marks, pH and Trans Epidermal Water Loss (TEWL) and child perception of skin 
irritation and wetness 
• 
assess fit and performance of the overnight pant products (fit images, leaks, product 
defects)  

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               5 
• 
Quality of Life (QoL) information of parent/legal guardian and child after each product 
usage period. 
             The following table shows which endpoints will be measured at which time and where on the child: 
Endpoint 
When Measured 
Where Measured 
Leaking & Pant Fit 
Before pant removal 
Waist front and back, crotch area, 
leg cuffs 
Child skin irritation 
and wetness 
perception 
 Directly before removing pant 
 Entire pant area  
Parent/ Legal 
guardian skin 
wetness perception 
 Directly after removing pant 
 Thigh, pubis, buttocks hips 
(Direct on skin) 
Parent/ child rash 
and pressure mark 
perception 
 ~30 seconds after removing pant 
 Thigh, pubis, buttocks, hips 
(Direct on skin) 
gpskin TEWL and 
SCH 
 ~5 minutes after removing pant 
 Thigh, pubis, buttocks, hips 
(Direct on skin) 
 Skin pH 
 Concurrent with TEWL measurements 
 Thigh, pubis, buttocks, hips 
(Direct on skin) 
AE, ADE, product 
defects 
Observed all the time and reported twice a 
day 
Observe child and pant 
 
• 
Leaking and Pant Fit: Mobile phone images of the pant on the child will be collected by the 
parent/legal guardian at home using their mobile device and the MyBabySkin app. Expert 
graders will evaluate pant fit from these collected images. 
 
• 
Child Perception: Child will be asked simple yes/ no questions to determine if they feel 
irritation or wetness. If yes, the parent/legal guardian will ask the child to point to location 
where they feel the irritation or wetness. 
 
• 
Parental Skin Perception: Parent/legal guardian will be trained to assess rash, skin 
pressure marks and skin wetness in the pant area. 
 
• 
Skin barrier integrity will be measured by trained parent/legal guardian who will be asked 
to measure the child’s skin pH and TEWL values in pant area using provided portable pH 
and gpskin devices. TEWL and pH are generally taken at several points in the pant area in 
to determine conditions over the entire area of the pant. The supra-pubic area is expected 
to be exposed to more wetness, as this site is closest to the urination point. However, when 
the children sleep on their back, the urine runs to the back and the buttocks can become 
wet. So, it will be very important to determine the sleep position of the kids and measure 
skin barrier integrity of front and back areas. 
 
Up to 30 children (approximate split of 15 males and 15 females) who meet inclusion/exclusion 
criteria will be enrolled in the clinical trial. S7 children will be enrolled in this clinical trial because 
nocturnal enuresis is most prevalent in children aged 4-7 and the pant design for S7 and S8 
products are similar. Therefore, the data generated for the S7 population can be used to support 
the S8 population. Children for this clinical trial will be enrolled by North Cliff Consultants in 
Cincinnati, USA.  Eligible subjects will be bedwetters who have wet the bed at least once a week 
or more over the past 3 months. The children should be accustomed to wearing an absorbent pant 
product overnight. They will be asked to use their own overnight pant every night for 3 weeks of 
the clinical trial and will be asked to use the NJ EU test pant every night for the other 3 weeks of 
the clinical trial. The order of the NJ EU product and own product will be randomized. Parents will 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               6 
be asked to refrain from using wet wipes to clean the child’s skin for the duration of the clinical trial 
(no test wipes will be provided). 
If a subject drops out of the clinical trial, they will not be replaced, due to the short duration of the 
clinical trial. 
 
Once qualified, parent/legal guardian will be asked to pick up the equipment (pH meter set, gpskin 
device, scale, and selfie light) from North Cliff Consultants.  They will receive training on how to 
handle the equipment and how to complete the questionnaires. Parent/legal guardian will be 
required to begin with the clinical trial after the training session. They will be given 2 days to practice 
with the instruments and MyBabySkin app before data is officially collected for the clinical trial.  
 
Parent/legal guardian will be instructed to complete a digital questionnaire twice daily (once in the 
morning before removing the used pant and once in the evening when applying the fresh pant) via 
MyBabySkin app. This will include taking four photos of the child wearing the pant (front, back and 
both hips) and measuring pH and gpskin values in four areas (upper thigh, hip, suprapubic area, 
and central buttock area). It includes capturing adverse events and compliance questions. 
Subjects will also be asked to complete a H&P questionnaire at the clinical trial start and at the 
end of each 3-week period and they will also be asked to complete an after-use questionnaire.   
 
This clinical trial will be submitted for IRB/ethics review.  
 
3.2 
Clinical Trial Procedures 
 
3.2.1 Visit 1 – Enrollment and Training (on Site) 
 
1. 
On the day of their appointment, a parent/legal guardian will be asked to come to 
the clinical site together with their participating child.  
 
2. 
Parent/legal guardian will be instructed to read the Informed Consent document 
but not sign until they meet with clinical personnel. They will be given the 
opportunity to have any questions answered.  They will be asked to sign two 
copies of the Informed Consent in the presence of clinical personnel. After 
verification of a legible signature, the parent/legal guardian will be instructed to 
keep one signed copy of the Informed Consent.  The clinical site will keep the 
other copy.  
 
3. 
Parent/legal guardian will be asked for demographic information and inclusion/ 
exclusion criteria to determine if their child is eligible to participate in the clinical 
trial.  Children will be weighed on a bathroom scale and have their body length, 
waist circumference (lying down and standing), thigh circumference and hip 
circumference measured by the parent under the supervision of a clinical staff 
member. The participating child must be present, so clinical personnel can verify 
the age, weight, Fitzpatrick scale and general health of the child. The child will 
also be asked to try on one of the overnight test pants to ensure proper fit. If 
eligible, parent/legal guardian will be asked about the typical habits and practices 
of their child during the MyBabySkin app registration (see Attachment C). 
 
4. 
The subjects will be asked to bring along a packet of their currently used overnight 
pant product so the test site can verify that this product brand qualifies as one of 
the allowed “own product brands” (current marketed disposable or reusable 
absorbent overnight pants/diapers or training pants/diapers). The brand name 
and lot code of this product will be documented. 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               7 
 
5. 
Subjects will be randomized to use either their current product, or, be distributed 
the NJ EU product, for the first 3-week test period of the study. If randomized to 
start with the NJ EU product, they will be asked to return any unused product at 
the end of the 3 weeks. If randomized to start with their own product, they will be 
instructed to use this brand exclusively for the 3-week test period. They will not 
be allowed to switch brands during this period. 
 
6. 
Subjects will be instructed to use an overnight pant every night for the duration of 
the study.   
 
7. 
The use of skin products like lotions, oils, powders, creams, sunscreens, wet 
wipes and moisturizing bubble baths will not be allowed to be used in the pant 
area and thighs, unless needed for medical reasons. Use of these skin 
preparations will be captured in the daily questionnaire via the MyBabySkin app 
(Attachment D). 
 
8. 
After enrollment, parent/legal guardian will receive the following items:  
 
• 
pH-Meter kit including 2 pH meters, KCl storage solution, Buffer pH4 and 
Buffer pH7 sachets, disinfectant alcohol pads 
• 
gpskin device 
• 
Two coin-cell batteries as back-up 
• 
Selfie-light (with USB charging cable) 
• 
Kitchen scale (balance) with USB charging cable 
• 
Skin marking pen 
• 
Measuring tape 
• 
Colored dot stickers 
• 
Written subject instructions 
 
9. 
Parent/ legal guardian will participate in a training session on the following:  
 
a. 
Review of MyBabySkin app questionnaire 
b. 
How to take photos using mobile phone & selfie light 
c. 
How to assess rash, imprints/marks on the skin 
d. 
How to assess skin wetness (feel) 
e. 
How and where to measure skin pH 
f. 
How to calibrate pH device 
g. 
How and where to measure gpskin values 
h. 
How to weigh the pant 
 
10. 
A demonstration of the MyBabySkin app will be conducted, and clinical staff will 
assist subjects in installing the needed apps and completing the registration 
(Attachment O). 
 
11. 
Parent/legal guardian will be asked to begin completing the questionnaire 
(2x/day) for 45 days. The first 2 days will be considered practice days and data 
from day 1 and 2 will be considered non-evaluable. 
 
 
3.2.2 During the 6-Week at Home Clinical Trial 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               8 
 
1. 
Parent/legal guardian will be asked to complete the questionnaire 2x daily for 45 
days.  
- 
Once in the evening when applying the fresh night pant 
- 
Once in the morning when removing the used pant 
 
2. 
In the evenings they will be asked to apply a fresh pant and wait ~15 minutes, 
before doing images, measurements, and skin assessments. In the mornings, 
they will be asked to take the images before they remove the pant and then 
remove the pant to do skin assessments. Approx. 5 minutes after removing the 
pant, they will be instructed to take the pH and gpskin measurements.  
 
3. 
The MyBabySkin app will lead them step-by-step through the skin and pant 
assessment process and the questionnaire has several questions to check 
compliance and ADEs and AEs throughout the clinical trial. It also has a chat 
function through which the parent/legal guardian can provide feedback and ask 
questions to the clinical site or sponsor. 
 
4. 
Parent/ legal guardian will be asked to measure skin pH and TEWL, assess skin 
wetness, rash, and pressure marks, enter pant wear time and weight, assess 
leaking, and take images of the pant fit on the child in standing position. If the 
overnight pant did leak, they will be asked to take an image of the wet stain on 
the pajama pant in the crotch area as well as front, back or sides in a standing 
position, so we can see the location and size of the leak.  
 
5. 
To dimension the size of the stain, they will be asked to put a provided sticker 
with known diameter on the pajama pant. For determining the level of gapping 
and sagging of the overnight pant, the parent/legal guardian will make a mark 5 
cm above the navel with a surgical marker and at the same height at the sides 
and back to determine how much the pant sagged overnight. A provided sticker 
with known diameter will be applied to the pant to determine the amount of 
sagging that occurred.  
 
6. 
Parents/legal guardian will be asked to calibrate the pH meter and gpskin device 
once a week to ensure it is working properly. The test site will calibrate the 
instruments on the day they are handed out to the parent/legal guardian and 
train them how to do the calibration. They will be asked to document the 
calibration once a week In the MyBabySkin App.  
 
7. 
Subjects will receive two pH meters at the start of the clinical trial. The parent/ 
legal guardian will be instructed to use only one of the pH meters for the study. If 
this pH meter gets broken, cracked or is not calibrating anymore, the 
parent/legal guardian will be instructed to use the backup pH meter provided to 
them. Should this occur, the parent/legal guardian should inform the study site 
via a comment in the MyBabySkin app or via email. In case the gpskin device 
should be broken or defective, they will be asked to contact the study site to 
arrange for a replacement device asap.   
 
8. 
The parent/legal guardian will be called via phone or video chat after the 2 
practice days to provide feedback after monitoring their data. Throughout the 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               9 
clinical trial the submitted data will be monitored and subjects will be contacted 
at least once per week (either during planned study visits or remote phone/video 
calls) so the study site can give feedback, check on progress, track lot codes of 
new purchased products and answer questions throughout the clinical trial. 
Feedback from subjects who participated in similar studies was that for remote 
studies it is very important for the study site to have regular contact with the 
subjects and receive feedback (positive and negative) on their progress. They 
appreciate knowing that they are doing the measurements and images correctly 
or whether they can improve something.  
 
9. 
The following topics will be assessed by the site or sponsor based on the app 
responses and will be discussed during the weekly phone calls: 
 
1. 
Resolution/Tracking of any AEs or ADEs 
2. 
Resolution/Tracking of Medication Use 
3. 
Feedback on data quality and study progress 
4. 
Compliance (reasons for missed questionnaires or study instructions not 
being followed) 
5. 
Reminder to calibrate the pH meter and gpskin device weekly 
6. 
Track lot codes of new purchased own products 
7. 
Answer questions the subjects may have 
 
3.2.3. Visit 2 – Return / Pick-up of Test Products After 3 Weeks (on Site) 
 
1. 
Parent/legal guardian will be asked to return to the test site to either return the 
unused test product or to pick up the test product for the final 3 weeks of the 
clinical trial, depending on their randomization.  
 
2. 
Parent/legal guardian will be asked to bring the gpskin device and the pH meter 
to the appointment 
 
3. 
Clinical staff will perform calibration and instrument checks to ensure equipment 
is in good working condition. 
 
4. 
Parent/legal guardian will be instructed on use of the test product or own 
product for the next 3 weeks. 
 
5. 
Parent/legal guardian will be asked to complete a QoL online questionnaire and 
an after-product use feedback questionnaire after the first 3 weeks of the trial. 
Part of the questions is to be completed by the parent/legal guardian and part of 
the questions is to be completed by the child with the help of the parent/legal 
guardian. 
 
 
3.2.4. Visit 3 – Return of Study Supplies and Close Out Visit  
 
1. 
Parent/legal guardian will be asked to return to the test site for the final visit.  
 
2. 
The following will be resolved and recorded by clinical personnel: 
 
1. 
Subject Accountability 
2. 
Resolution/Tracking of any ADEs and AEs 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               10 
3. 
Resolution/Tracking of any Medications Used 
Document lot codes of any new purchased own products 
4. 
Return of instruments (balance, selfie light, gpskin and pH 
meter/accessories) 
5. 
Return of unused test pants (if applicable) 
 
3. 
Parent/legal guardian will be asked to complete a QoL online questionnaire and 
an after-product use feedback questionnaire after the last 3 weeks of the trial. 
Part of the questions is to be completed by the parent/legal guardian and part of 
the questions is to be completed by the child with the help of the parent/legal 
guardian. 
 
4. 
Subjects will be released from clinical trial and be allowed to go back to their 
normal habits. 
 
5. 
Compensation details will be provided to parent/legal guardian. Payment will 
occur after all equipment is returned and verified by clinical personnel. Any 
damaged equipment should be returned to the site for safe disposal. Subjects 
will not be charged for equipment that was unintentionally broken or lost. At the 
completion of this visit, the subject will have completed the clinical trial. 
 
 
3.2.5. Clinical Trial Schedule of Events 
 
 
 
3.3. 
Selection of Clinical Trial Population 
North Cliff Consultants will recruit children meeting the inclusion/exclusion criteria from their 
Cincinnati database.  
 
3.3.1 Inclusion Criteria 
 
Inclusion and Exclusion criteria will be assessed at the Enrollment visit in an individual 
conversation with parent/legal guardian (with child present).   
Procedure 
Visit 1: 
Enrollment 
and Training 
Visit 2: 
Product pick 
up and 
instrument 
check (3 
weeks after 
visit 1) 
AT HOME: 
Clinical Trial 
Mode 
Days 1 – 45 
Weekly 
Phone Calls 
(after 2 days 
and then 
weekly, if no 
study visits 
planned for 
that week) 
Visit 3: 
Final Visit 
Informed Consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Inclusion/Exclusin 
X 
 
 
 
 
Anthropometry 
X 
 
 
 
 
Subject Instructions (training session)  
X 
 
 
 
 
H&P Questionnaire (app registration) 
X 
 
 
 
 
Randomization 
X 
 
 
 
 
Product Distribution (per randomization) 
X 
X 
 
 
 
Compliance/ AE Resolution 
 
X 
X 
X 
X 
Twice Daily Questionnaire (via app) 
(photos and measurements) 
 
 
X 
 
 
QoL (online parent/child) 
 
X 
 
 
X 
Subject Accountability 
 
 
 
 
X 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               11 
 
Subjects are eligible for enrollment if the parent/legal guardian responds positively (“Yes”) 
to the following questions: 
 
INCL01: 
Have you read and understood the Informed Consent document?  
INCL02: 
Is your child generally healthy? [excluding acute conditions such as flu/cold 
symptoms, diarrhea, fever, ear infection, etc.] 
INCL03: 
Is your child 4-7 years of age? 
INCL04: 
Does your child weigh approximately 37–63 pounds and fit into the test pant    
                  [Clinical trial personal to confirm fit]?  
INCL05: 
Thinking of the past 3 months, does your child wet the bed at night at least once 
per week? 
INCL06:    Is your child currently using overnight pants or diapers? 
INCL07: 
Is your child willing to use their usual and/or supplied overnight pant products every 
night for the duration of the study? 
INCL08: 
Are you and your child willing to refrain from using wet wipes in the pant area for 
the duration of the clinical trial? 
INCL09: 
Are you willing to refrain from enrolling your child in other clinical or consumer 
studies for the duration of this clinical trial? 
INCL10: 
Are you and your child willing to refrain from using lotions, creams, ointments, oils, 
moisturizing bubble baths, powders, sunscreen and/or skin preparations in the 
child’s pant area and on thighs for the duration of this clinical trial, unless required 
for medical reasons? 
INCL11: 
Are you and your child willing and able to comply with all study instructions? 
INCL12: 
Do you have an iPhone 7 (or higher) with iOS 13.0 operating system (or higher) or 
do you have an Android smartphone with operating system Android 9 (or higher) 
installed? 
INCL13: 
Are you willing to install the required apps for the execution of the clinical trial  (e.g., 
TestFlight app for iPhones, MyBabySkin app and gpskin app)? 
INCL14: 
Are you able to fill in the required questionnaires in English? 
INCL15: 
Are you willing to complete the MyBabySkin app questionnaires twice daily for 6 
weeks, once in the morning when removing the pant and once more in the evening 
when applying the pant? 
 
3.3.2 Exclusion Criteria 
 
Subjects are ineligible for enrollment if the parent/legal guardian responds positively (“Yes”) to 
any of the following questions: 
 
 
EXCL01: Does your child have any acute or chronic skin conditions (excluding skin rash) in 
or around the pant area? 
EXCL02: Does your child currently have (or have a history of) any significant illness or chronic 
medical condition (SITE: that in the opinion of the investigator may negatively 
impact child’s health and/or clinical trial results, for example medications to 
treat nocturnal enuresis,antibiotics, antihistamines, anti-inflammatory medications, 
corticosteroids, mediations to treat yeast infection or similar)? 
EXCL03: Is your child currently using any medications? (SITE: that in the opinion of the 
investigator may negatively impact child’s health and/or clinical trial results)? 
EXCL04: Does your child currently wear absorbent products during the day? 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               12 
EXCL05: Does your child suffer from any other lower urinary tract symptoms (e.g., increased 
frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a 
history of bladder dysfunction? 
 
3.3.3 Compliance and Habits & Practice Questions 
The following questions will be asked twice daily (am/pm) in the MyBabySkin app: 
 
1. 
Did your child experience any of the following health conditions since you 
last completed the questionnaire: diarrhea, fever, other illness, injury, or 
none of the above? 
2. 
Has your child taken, or did you apply any of the following since you last 
completed the questionnaire: vaccination, medication, or none of the 
above? 
3. 
Did your child bathe since you last completed the questionnaire? 
4. 
Did your child swim since you last completed the questionnaire? 
5. 
Did you or your child use cosmetics in the pant area since you last 
completed the questionnaire (lotion, oil, cream, powders, sunscreen, 
moisturizing bath additives, wet wipes, etc.)? 
6. 
Which pants did you use since you last completed the questionnaire?   
 
 
3.3.4 Data Measurement Collection 
The following information will be collected twice daily (am/pm) in the MyBabySkin app: 
1. 
Leaks (If yes, parent/legal guardian will be asked to take an image of the 
wet stain on the pant and send the image to the site) (Attachment E) 
2. 
gpskin [thigh, hip, suprapubic area, buttock] (Attachment M + Q) 
3. 
Skin pH [thigh, hip, suprapubic area, buttock] (Attachment L + Q) 
4. 
Parent/child wetness assessment [thigh, hip, suprapubic area, buttock] 
(Attachment K) 
5. 
Photos of pant on child [left hip, right hip, front, back] (Attachment F) 
6. 
Parent/child assessment of rash [hips, genital, buttock, perianal] 
(Attachment J) 
7. 
Parent/child assessment of pressure marks [hips, genital, buttock] 
(Attachment J) 
8. 
Pant weight (loaded pant mornings / fresh pant evenings) 
9. 
Hours of pant wear 
10. Pant contents [urine, both urine & BM, parent removed solid BM, nothing]  
11. Number of pants used since last questionnaire 
12. Observations during pant removal: Did you notice any of the following: 
nothing, product defects, topsheet sticking to skin, pant fluff or particles 
sticking to skin, other? 
 
3.4 
Subject Identification 
The 4-digit unique panelist number in addition to their 3-letter code will identify subjects throughout 
the clinical trial. Boy subjects start with 1001 and girl subjects start with 2001. Each panelist will 
also get a 3-letter code to help identify them in case they accidentally enter a wrong subject 
number.  
 
3.5 
Subject Accountability 
A Subject Accountability form will be completed at visit 3 for all subjects enrolled into the clinical 
trial. 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               13 
 
3.5.1 Removal of Subjects from the Clinical Trial 
Participation in this clinical trial is completely voluntary. After admission to the clinical trial, the 
subject may withdraw at any time for any reason and will be asked to report such reason fairly 
and accurately. The Principal Investigator or clinical trial representative may elect to 
discontinue a subject’s participation at any time if they deem it necessary or if it is in the 
subject’s best interest. Reasons for subject withdrawal or discontinuation will be documented 
in Subject Accountability. 
 
3.5.2 Replacement of Subjects 
If a subject drops out of the clinical trial, they will not be replaced, due to the short duration of 
the clinical trial. 
 
3.6 
Products   
All participants will be asked to use either their current night pant product or the NJ EU pant product 
during the clinical trial (order based upon randomization). 
 
 
Test product: Ninjama S7 EO boy product produced in Targowek plant in Poland (product 
details on file in the QA documentation). The boy and girl versions of the product has the same 
technical design, only the printed graphics on the outside of the product are different. The 
graphics is not impacting the clinical trial results. 
 
Own product: Any disposable overnight pant/diaper, disposable training pant/diaper or reusable 
cotton pant/diaper available on the market for children age 4-7. Parent/legal guardian will purchase 
and use their own overnight pant as agreed upon in the enrollment visit. They will be asked not to 
switch brands during the 3 weeks they use their own product. Lot codes of own product will be 
documented. 
 
 
3.7 
Assessment and Collection Details 
3.7.1 Skin Rash and Pressure Mark Grading (Attachment J) 
The parent/legal guardian will use the following multi-level grading scale to assess rash and 
skin marking in the following regions of the pant area: hips, genital area, buttock area, 
perianal area (only rash grading): 
▪ 
None 
▪ 
Mild 
▪ 
Moderate 
▪ 
Severe 
 
3.7.2 Wetness Assessments (Attachment K) 
The parent/legal guardian will use the following multi-level grading scale to assess skin 
wetness, by touching the skin: 
▪ 
Dry 
▪ 
Slightly Damp, but acceptable 
▪ 
Damp and not acceptable 
▪ 
Wet 
 
The child will be asked if they feel wetness in the pant area (yes/no). If yes, they will be 
asked where they feel the wetness.  
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               14 
3.7.3 gpskin Measurements (Attachment M) 
The TEWL and Stratum Corneum Hydration (SCH) measurements will be taken with a gpskin 
Barrier Pro device from gpower Inc. of Korea. The child will be standing up while 
measurements are taken. These measurements will be taken for 10 seconds with data being 
displayed on the Smartphone app to give a mean TEWL value (g/m2/hr) and a mean SCH 
value (arbitrary units). The values will be recorded in the MyBabySkin app. Measurements will 
be taken at the thigh (uncovered control), hip, supra pubis (genital) and central buttocks. 
Reference diagrams in the Attachment.  
Measurements will be taken by a parent/legal guardian who has been trained to properly use 
the device.   
 
The serial number of the gpskin device used in this clinical trial will be recorded in the clinical 
trial records.   
 
Parents/legal guardians will be asked to calibrate the devices once a week and report the 
calibration in the MyBabySkin app. 
 
3.7.4 Pant Weight/Wear Time (Attachment N) 
Pant weight will be measured on a kitchen scale after pant removal. Pant wear time will be 
recorded in the mornings.  Both measurements will be recorded in the MyBabySkin app.  
 
3.7.5 pH Measurements (Attachment L) 
Skin pH measurements will be taken by a trained parent/legal guardian using a portable 
Hanna Skin pH meter. The child will be standing up while measurements are taken. 
These measurements will be recorded in the MyBabySkin app. pH measurements will 
be taken at the thigh (uncovered skin control), hip, supra pubis and central buttocks.  
Parents/legal guardians will be asked to calibrate the devices once a week and report the 
calibration in the MyBabySkin app. 
 
3.7.6 Photos (Attachment E, F & G) 
Photo images will be taken by parent/legal guardian to collect images of the pant fit using the 
MyBabySkin app on their mobile phone. A skin mark will be made 5 cm above the center of 
the navel and skin marks will be made at the same height on the back and at the sides (above 
hips). The child will be asked to stand up with legs slightly apart (front and back images) and 
using the provided illuminated selfie light. For the hip images the child will stand upright and 
will bend the leg closest to the camera at a 90° angle, so one can see if there are gaps at the 
leg cuffs.  
 
Parent/legal guardian will also be asked to take an image of wet stains in the pajama pant, so 
we can determine where the leak happened and how big the stain was. Images should be 
taken of the pant on the child in the crotch area, front, back or sides, depending on where the 
stain is. 
 
Photos will be stored without personally identifiable information and in such a manner as to 
restrict access through password protection.  For example, the mobile phone used to take the 
photos will not store the photos on the photo roll or cloud, but they will be stored inside the 
password protected app. Parent/legal guardian will submit photos at the end of each 
questionnaire into a limited-access P&G database via encoded transfer. The folder used to 
house the photos on the sponsor’s drive will have limited access. Access to this drive is granted 
by the BFF Clinical-Micro Director.   

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               15 
 
Images will be assessed by an expert grader to look for potential incorrect use of the product 
(e.g., worn the wrong way), product defects, pant sagging and pant gapping.   
 
3.7.7 Twice Daily Questionnaire in MyBabySkin App (Attachment D) 
Parent/legal guardian will be asked questions twice daily (once in the morning when removing 
the night pant and once in the evening when applying the fresh night pant) regarding their 
perception of the skin wetness and their perception of skin rash/pressure marks. They will be 
asked to take photos, collect pH and gpskin data and answer questions about the child’s H&P 
and overall health. The questions will be asked via the MyBabySkin app that parents will use 
at home to collect data on their mobile device. 
 
3.7.8 Skin Irritation Perception  
Child will be asked their perception of skin irritation by picking one of the following options. If 
they pick an option, they will be asked where they feel the irritation.  
• 
Nothing  
• 
Skin is burning/stinging 
• 
Skin is itching/tingling 
• 
Skin is feeling warm/hot 
 
 
4. Statistical Methods  
4.1 
Statistical Analysis 
All statistical analyses will be the responsibility of the Sponsor.  A separate statistical analysis plan 
is in Attachment B.  
  
4.2 
Determination of Sample Size 
This data will be used to bridge to a wealth of existing P&G Baby and FemCare AI clinical trial 
data, therefore sample size was based on practical limitation, not on statistical considerations.  
 
5. Risk Assessment- See Attachment A 
 
6. Conduct of the Clinical Trial  
6.1 
Protocol Amendment(s) 
No amendments to the protocol will be permitted without approval from both the Sponsor and 
Principal Investigator and where applicable, the Ethics Commission. Such changes and the 
reasons for those changes will be documented in writing and signed by the Principal Investigator 
if required. Approval by the Ethics Commission (if applicable) must be obtained prior to initiation 
of the amendment. 
The Principal Investigator, the project manager or their designee will communicate any deviations 
from the protocol to the Sponsor as soon as possible. The Principal Investigator is responsible for 
documenting any deviation in the clinical trial file and in the final report. 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               16 
7. Obligation of the Investigator 
This clinical trial will be conducted in accordance with the applicable ISO 14155 Clinical 
Investigation of Medical Devices for Human subjects – Good Clinical Practices (GCPs)  and GCPs 
according to the International Conference on Harmonization (ICH). The Principal Investigator will 
perform or directly supervise the performance of all the services described herein, or incidental to 
those described herein, in accordance with the highest standards of medical and clinical research 
practice. Delegation of any clinical trial responsibility will be documented in writing. The 
Investigator will also be required to submit a report documenting clinical trial execution. 
 
7.1 
Adherence to Protocol 
The Investigator will have responsibility for all aspects of the clinical trial, including but not 
limited to ensuring the signed/approved protocol is followed exactly. 
Any deviations from this protocol will be discussed with the Sponsor and appropriately 
documented. No modifications of the protocol will be permitted without the approval from 
the Sponsor and the Investigator. Such changes must be documented in writing as soon 
as possible. 
 
 
7.2 
Advertising 
If an Investigator chooses to advertise for subjects, whether in professional or consumer 
publications, radio, television, or any other means, all advertising must be approved by the 
Sponsor prior to initiation.  
 
7.3  
Subject Consent 
Each subject’s parent/legal guardian must sign and date an Informed Consent to allow their child 
to participate in the clinical trial. Each parent/legal guardian will be given the opportunity to have 
his/her questions answered to their satisfaction. Without this signed document, a child will be 
ineligible to participate in this clinical trial.  
 
This consent form will comply with all applicable regulations governing the protection of human 
subjects. The elements of Informed Consent and the documentation of Informed Consent are 
specified in ICH GCPs chapter 4. A signed copy of the Informed Consent will be kept by the 
parent/legal guardian of the child and the Investigator will retain a signed copy 
 
Subjects may withdraw from participation in the clinical trial at any time. Additionally, the 
Investigator may remove subjects from the clinical trial if it is in the best interest of the subjects. 
The reason for all Investigator removals from the clinical trial will be documented. 
 
 
7.4 
Data Collection 
The Principal Investigator is responsible for ensuring that data are collected and reported 
according to the clinical trial protocol. 
 
Data Collection System 
A newly developed tool, MyBabySkin app, will be the primary tool used for data collection.  This 
app was developed by an outside vendor (Vertex). 
 
Additionally, the Electronic Case Report Forms (ECRF) data capture system, a database 
developed through a validated, Electronic Records/Electronic Signatures (ERES)-compliant 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               17 
platform (21 CFR Part 11) will be utilized to collect data by the site (e.g.,  Demographics, 
Inclusion/Exclusion, Anthropometry, Adverse Events, Medications, General Comments, and 
Subject Accountability).  
 
All protocol specified data included in the clinical trial database will be collected as e-source. 
 
7.4.1 Source Documents 
 
Direct data entry will be used via the MyBabySkin app and ECRF.  The electronic records 
are considered to be source documents.  
 
There will be periodic monitoring of the site on the critical enrollment days and the study 
conduct via remote data reviews. Data entered by the parents through the MyBabySkin 
app will be monitored periodically to check for compliance via remote monitoring.  
 
7.5  
Adverse Events or Adverse Device Effects 
An Adverse Event (AE) is defined as any unfavorable and unexpected medical occurrence in a 
subject. An Adverse Device Effect (ADE) is defined as any AE related to the use of the 
investigational medical device. This definition includes AEs resulting from insufficient or 
inadequate instructions for use, any malfunction, use error or intentional misuse of the medical 
device. Each day (following the initial visit), the parent/legal guardian will be asked if there has 
been any change in the child’s health (illness or injury) since the previous visit or the previous time 
the questionnaire was filled in. Changes in health will be documented as an AE or ADE as 
appropriate, regardless of the causality relationship with product use. All AEs and ADEs will be 
followed to resolution. 
 
7.5.1 Adverse Event and Adverse Device Effect Reporting 
In the MyBabySkin app, the parent/legal guardian will be asked twice daily about their 
child’s health and medication intake.  Based on the information provided, Sponsor and 
PI will determine if it is appropriate to record as an Adverse Event or Adverse Device 
Effect and will contact the parent/legal guardian for more information. Such an 
occurrence does not necessarily have to have a causal relationship with product use. 
Due to the nature of this clinical trial, skin irritation in the pant area (diaper rash) will not 
be documented as an Adverse Event or Adverse Device Effect given it is one of the 
end points of interest for the clinical trial. However, if a skin reaction occurs in the pant 
area which causes the parent/legal guardian to seek medical attention, outside the 
normal follow-up given to the child within the clinical trial, this will be documented and 
followed in the same manner as other Adverse Events or Adverse Device Effects.  
The Investigator or designee will review each Adverse Event Report and complete the 
form based on the following decision charts: 
Chart 1: Categories of ADE and AEs 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               18 
  
Chart 2: AE categorization flow chart 
 
The Investigator or designee will review each Adverse Event Report and complete the 
form based on the following definitions: 
 
 
 
Severity: 
o Mild - normal activities unaltered, AE or ADE is annoying, but tolerable 
o Moderate - normal activities altered or AE or ADE requires intervention 
o Severe - unable to undertake normal activities or is incapacitated 
 
 
 
Investigator's Opinion of Causality: 
o Not Related - there is no medical evidence to suggest that the AE or ADE may be 
related to product usage 
o Doubtful – there is no medical evidence to suggest that the AE or ADE may be related 
to product usage, or there is another more probable medical explanation 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               19 
o Possible - there is possible evidence to suggest that the AE or ADE could possibly be 
related to product usage 
o Probable - there is probable evidence to suggest that the AE or ADE is probably related 
to product usage 
 
 
 
Action Taken by Investigator: 
o None - no change in product usage 
o Reduced/Interrupted - product usage reduced or temporarily interrupted 
o Discontinued - product usage discontinued. 
 
Note: Actions taken by parent/guardian may be documented in General Comments. 
 
The Investigator will decide on a case-by-case basis as to whether any subject should 
be dropped from the clinical trial. If the Investigator(s) or subject decides to discontinue 
clinical trial participation, this should be documented and filed with the Sponsor within 
72 hours. All adverse events and adverse device effects will be followed until resolution 
or until the Investigator deems it safe to discharge the subject.   
 
7.5.2 Serious or Unexpected Adverse Events or Adverse Device Effects Reporting 
 
A Serious Adverse Event (SAE) or Serious Adverse Device Effect (SADE) is defined 
as any unexpected medical occurrence that at any exposure: 
 
1. 
Results in death 
2. 
Is life-threatening 
3. 
Requires in-patient hospitalization or prolongation of existing hospitalization 
4. 
Results in persistent or significant disability/incapacity 
5. 
Results in a congenital anomaly/birth defect 
6. 
Requires medical or surgical intervention (devices) 
7. 
Is medically significant 
 
All SAEs and SADEs will be recorded on the written and/or electronic SAE or SADE 
form and tracked in this clinical trial. 
 
The Investigator/Designee must contact the Sponsor within 24 hours to discuss 
potentially serious or unexpected AEs. During normal business hours: Susanna Brink 
+49 6196 89 4474. 
 
7.6  
Device Deficiency Reporting 
Device deficiency is defined as the inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, suability, safety, or performance. Device deficiencies include 
malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including 
labelling.  In this clinical trial we will document any product or material defects, potential wrong 
application (via pant fit images), leaking/failure of overnight absorbent pants and all AEs /ADEs.   
 
All device deficiencies of the investigational products will be documented throughout the clinical 
trial and managed by the sponsor in accordance with written procedures for the control of a non-
conforming product. The sponsor shall take, where applicable, and appropriate, and corrective 
actions to protect the safety of subjects, users, and other persons. Device deficiencies of the 
comparator, if applicable, shall be documented.  
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               20 
Device deficiencies that did not lead to an adverse event, but could have led to a serious adverse 
device effect: 
 
1. if either suitable action had not been taken 
2. if intervention had not been made, or 
3. if circumstances had been less fortunate 
 
shall be reported to the sponsor, who will prepare the needed Clinical Evaluation Report 
documentation and report the potential risk to the EC/IRB and national authorities as applicable. 
The sponsor will decide whether the risk analysis needs to be updated and assess whether 
preventative or corrective action is required.   
 
7.7 
Investigator’s Final Report 
The Investigator will provide a Final Report within approximately 30 days from the completion of 
the in-life phase of the clinical trial. The report will consist of a description of the conduct of the 
clinical trial including subject enrollment, subject demographics, protocol deviations, subject 
dropouts, and a discussion of AEs. Data analyses or data interpretation, if any, may be included 
in a separate document. 
 
7.8  
Records Retention 
The Investigator(s) must retain the subject identification codes, Informed Consent documentation, 
CRFs, medical records, and other source data for a minimum of 2 years after clinical trial 
completion. The Investigator(s) must receive written authorization from the Sponsor before 
destroying any clinical trial document. 
 
The Investigator(s) will make the records available for inspection and copying upon the request of 
an authorized employee of a government authority or the Sponsor, at reasonable times. 
 
In the event the Investigator(s) retires, relocates, or for any other reason withdraws from the 
responsibility for maintaining records for the period of time required, custody of the records may 
be transferred to another person who will accept responsibility for the records. Notice of such a 
transfer must be given in writing to the Sponsor. 
 
The sponsor will maintain clinical records according to P&G Records Management Guidelines. 
 
7.9  
Publications 
All data collected during this clinical trial is the sole responsibility of the Sponsor. No publication 
by the site or any of the non-employees of the sponsor is allowed from the results of this clinical 
trial. The Sponsor reserves the right to withhold consent for publications due to the confidential 
nature of the data. Subjects will be identified only by the assigned four-digit code and no identifiable 
personal information will be included. 
 
8. Sponsor Clinical Trial Management 
8.1 
Data Quality Assurance 
The following steps will be taken to ensure the accuracy, consistency, completeness, and reliability 
of the data: 
 
• 
Source/CRF review, 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               21 
• 
Data management quality control checks, and 
• 
Statistical quality control checks. 
 
In addition, a representative from the Sponsor may conduct periodic audits of clinical trial 
processes, including, but not limited to, a review of the Investigator’s Trial Master File (TMF), 
Standard Operating Procedures (SOPs) pertaining to the clinical trial, and training records of staff 
involved. 
 
 
8.1.1 Monitoring 
Prior to the commencement of the clinical trial, an initiation meeting will be held with 
the appropriate clinical trial site personnel to review the objectives and procedures of 
the clinical trial and any other training needs associated with the clinical trial and 
protocol execution. 
 
This clinical trial will be monitored by Sponsor representatives at all stages of conduct 
from inception to conclusion in accordance with and ICH GCPs chapter 5. 
 
8.2  
Clinical Trial Termination 
The clinical trial will be terminated upon completion of all subject treatments and evaluation. The 
Sponsor may discontinue the clinical trial at any time. In any case where this happens, the Principal 
Investigator and/or designee will return all clinical trial supplies, and equipment to the Sponsor. In 
addition, all data which has been collected up to that point will be turned over to the Sponsor at 
that time. 
 
8.3 
Sponsor’s Final Report 
A final report will be prepared by the Sponsor at the conclusion of this clinical trial. The Sponsor’s 
final clinical trial report will summarize the method, data, and conclusions. Source data may be 
retained by the testing facility. The original source data will be maintained according to the Principal 
Investigator’s standard operating procedure. A copy of the source documents may be obtained 
upon request of the clinical trial Sponsor. 
 
 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               22 
Attachment A 
Risk Assessment 
 
Product Safety 
 
No safety issues are anticipated with this clinical trial as outlined. Children participating in this clinical trial are using 
marketed products or products that are close to being marketed. From products purchased on the market, we can 
assume that they have been tested and evaluated for their safety in daily use. Children will be asked to use these 
products as intended.  
 
For the NJ EU test products, a full risk assessment according to the ISO 14971 standard is being conducted and will 
be summarized in a separate document before the start of the clinical trial.  
 
 
The P&G company has a 20+ year history of baby diaper clinical data (0-36 months) to show that our diaper and 
pant technology is safe to use and effective for managing urine gushes in a baby and toddler population. The P&G 
company also has adult (18+ years) female incontinence products in the EU market, including absorbent heavy 
incontinence pants, that are classified as Class 1 Medical Devices, which were demonstrated to be safe to use and 
effectively manages urine gushes of adults as seen in the statement of compliance from the CER report dated Feb 
2020 [1]. Since Aug 2020 the P&G company markets a similar Ninjamas night-time pant product in the USA for 
bedwetting children aged 4-12 years. (Same age group and intended use as NJ EU product) and P&G markets a 
training pant (BabyDry Pants S7) in the EU. Based on the Post Market Safety Surveillance data of similar products 
in the EU und US market (BabyDry Pants, FemCare AI Pants, NJ US pants), we have reason to believe that the NJ 
EU product will have no safety related issues when used as an overnight pant for children aged 4-12 years, based 
on skin and health related AEs. [2]  
 
 
Based on our current knowledge about this product and similar marketed products, we conclude the following 
statement, which will be updated based on the outcome of this clinical trial: 
 
Statement of Compliance for Children’s Nocturnal Enuresis Devices 
It is understood that similarity between intended use and indications for use exists between the Procter & 
Gamble Children’s Nocturnal Enuresis Devices and competitor products. Such devices serve as 
morphotypes. Procter & Gamble Children’s Nocturnal Enuresis Devices when used under the conditions and 
for the purposes intended, will not compromise the clinical condition or the safety of patients, or the safety 
and health of users or, where applicable other persons. The benefit of Procter & Gamble Children’s Nocturnal 
Enuresis Devices outweighs the risks associated with the product.  
 
Clinical risk identified in risk management has been adequately addressed for use in this clinical trial. This 
risk associated with the product is very minimal compared to the benefits of the product. Clinical investigation 
performed on similar Procter & Gamble pull-up pants identified no serious adverse events and no 
withdrawals due to adverse events. Procter and Gamble pull-up pants were well tolerated by the subjects 
with no product-related adverse events.  
 
Procter & Gamble Children’s Nocturnal Enuresis Devices are very simple devices and easy to use. No 
specific training is required to use this product. There is full consistency between current knowledge/ the 
state of the art, the available clinical data, the information materials supplied by the manufacturer, and the 
risk management documentation for Procter & Gamble Adult Children’s Nocturnal Enuresis Devices. 
 
  
As with any absorbent pant or diaper, it is possible in exceptional cases that these products may cause skin 
reactions like redness, blisters, or sores. These skin reactions are usually temporary and usually need no medical 
treatment, nor are they dangerous to the health. The risk of allergies cannot be totally excluded but can be 
considered very unlikely for these products. For subjects in this clinical trial, we do not expect any further risks 
apart from potential skin reactions (like redness). In case your child has some skin reactions (redness, swelling or 
blisters) during this test that concerns you, please contact the clinical trial personnel. 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               23 
Study Safety: 
 
For the twice daily questionnaire, the parent/legal guardian will be asked to touch the child's skin in the pant area. 
Parent/legal guardian will be instructed to wash their hands before and after for hygienic reasons.  
 
The selfie light should only be used to assist parent/legal guardian when taking images. When using selfie lights, 
parent/legal guardian are instructed not to shine the light in the eyes of babies and pets.  
 
Parent/legal guardian will be asked to use a pH meter to measure skin pH and a gpskin device to measure skin 
hydration. The pH meter is made of glass and can break. Parent/legal guardian will be asked to take precautions 
when using the instrument to avoid the risk of glass breakage and not to use a broken device.  
 
Parent/legal guardian will receive training on how to use these measuring devices correctly. They will be asked to 
ensure all instruments are switched off when not in use. These devices are not toys and should only be handled by 
an adult. Parent/legal guardian will be reminded to keep these devices out of the reach of children and pets. In 
addition, the associated chemicals (storage solution and buffer solutions) should be kept in a safe place. These 
solutions are not dangerous when swallowed.  
 
In case the instruments get contaminated or dirty, parent should wipe with a provided alcohol wipe. They should not 
immerse any devices in water or rinse under running water. Parent/legal guardian will be instructed to disinfect all 
devices after use with an alcohol wipe to prevent bacterial growth.  
 
 
 
 
 
 
 
 
 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               24 
Attachment B 
Statistical Analysis Plan 
 
Study Populations 
The Intent-to-treat (ITT) population is defined as all subjects who experienced the application of the 
assigned study product. The Per Protocol (PP) population includes subjects in the ITT population who 
have no serious inclusion/exclusion violations, no serious continuance criteria violations, no serious 
concomitant medication violations, and high study product compliance. The ITT population will be used 
for the safety analysis. Analyses of the Per Protocol population will be done to better understand the 
data. 
  
Prior to the statistical analysis, all data will be checked for accuracy, completeness, and compliance to 
the study protocol. Subject evaluations will be checked for compliance to the study protocol regimen and 
subjects will be assessed for compliance to the protocol inclusion/exclusion criteria.  Additionally, 
investigator comments will be assessed for extraneous factors that could affect the usefulness of the 
subject’s data.  Non-evaluable observations and the rationale, along with the method for handling the 
observations will be documented by the sponsor prior to analysis of the data.  
 
Period and carryover effects will be evaluated for potential influence on the results.  Means will be plotted 
by periods to understand these effects. 
  
Summary descriptive statistics will be provided for all parameters. Ninety-five percent confidence 
intervals (CIs) will be constructed for all clinical assessments for each treatment code. Any data reported 
as ‘unable to evaluate’ will be treated as missing and excluded from the analysis. 
 
The methods used for the analysis will include but not be limited to a variety of parametric and non-
parametric statistical methods based on the distribution/characterization of the data. 
 
The following endpoints will be investigated.  
 
General Safety: 
 
1. 
ADE (adverse device effect) and AE (adverse event) tracking twice daily via a safety in-
use diary. We will list a summary of the product related ADE and AEs for both treatment 
periods and the PI, Sub-PI, Statistician and Clinical Scientist will make a recommendation 
whether the product safety of Ninjamas is comparable to current product based on the 
medical and clinical evidence of the reported AE and ADE data.  
Product Fit and Performance: 
 
2. 
Product performance in terms of urine leaking (yes/no). We will calculate the percentage 
of leaks from loaded pants only. When comparing both products, Ninjama EU option 
should not be more than 2% worse than current product).  
 
3. 
Product or material defects that can lead to product failure or safety risks. All product 
defects will be summarized and categorized as potential reason for product failure (leaks) 
or safety risk.   
 
4. 
Pant fit images will be investigated by an expert grader to identify any application errors 
(e.g., applied wrong way) and to see how well the overnight pant (wet or dry) is staying in 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               25 
place. We will identify if sagging or gapping of the pant  led to leaking or if a bad fit led to 
skin irritation or severe pressure marking.  
 
5. 
Images of the wet stain on the overnight pajama pant will help identify the size of the stain 
and where the pant was leaking. This will be compared with the pant fit images.   
 
Skin Health 
 
6. 
Parental skin rash perception (none/mild/moderate/severe). We will calculate the 
cumulative number of moderate and severe scores on a weekly basis. When comparing 
both products, the Ninjama EU option should not be more than 2% worse than current 
product on moderate and severe scores. We expect to see carry-over effects in week one 
of each usage period. 
 
7. 
Parental overall skin health condition (excellent, very good, good, fair, poor). We will 
calculate the cumulative number of fair and poor scores on a weekly basis. When 
comparing both products, the Ninjama EU option should not be more than 2% worse than 
current product on fair and poor scores. We expect to see carry-over effects in week one 
of each usage period. 
 
8. 
Skin barrier integrity, via skin pH and TEWL measurements taken by trained parent 
before overnight pant application and 5 minutes after overnight pant removal (Thigh, hip, 
sura-pubic, buttock). Each site will be investigated separately. We will plot  individual pH 
and TEWL graphs over time and calculate the weekly average for each panelist. We 
expect to see carry over effects in week 1 of each period. 
 
9. 
Parental skin dryness perception (acceptable wetness / not acceptable wetness). We will 
calculate the percentage of unacceptable wetness scores from loaded pants. When 
comparing both products, Ninjama EU option should not be more than 2% worse than 
current product). 
 
10. Skin irritation perception from child (burning/itching/ stinging/tingling/feeling of heat). We 
will calculate the cumulative number of skin irritation scores on a weekly basis. When 
comparing both products, Ninjama EU option should not be more than 2% worse than 
current product on moderate and severe scores. We expect to see carry-over effects in 
week 1 of each usage period. 
 
11. Parental pressure mark perception on skin (none/mild/ moderate/ severe). We expect the 
belt design of the NJ EU pant to have more pressure marks than other overnight pants to 
ensure a better fit. We will calculate the cumulative number of severe pressure mark 
scores over 3 weeks. When comparing both products, Ninjama EU option should not be 
more than 2% worse than current product in terms of severe pressure marks). 
 
Quality of Life 
 
12. Use QoL measures at the end of each usage period for potential claims. QoL data will be 
summarized as an average for all subjects after each usage period and the Ninjama EU 
product will be compared with usual product used. 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               26 
Protocol Amendment I 
CSD2021096/ NCCI #12-2103 
OVERNIGHT PANT SAFETY-IN-USE DIARY CLINICAL TRIAL FOR CHILDREN WITH NOCTERNAL 
ENURESIS 
 
Rationale for amendment: 
1. Correction of mistake in exclusion criteria. List of medication examples are mentioned in EXCL 2, but 
should be listed in EXCL 3.   
2. Clarification of blinding of sponsor. Blinding of the sponsor representatives will be very difficult, due to 
the diary question about what product they used and the photos. Therefore the CTMs and DM cannot be 
fully blinded when they download the data, but all attempts will be made to blind the statistician and 
clinical scientist until after the database was locked. Also data for the evaluability meeting will be blinded 
by coding the options Own product and test product.  
3. Include stratification criteria into the protocol. 
4. Update the number of subjects enrolled to 32 instead of 30. 
 
Amended Protocol Sections for #1: 
3.5.3 Exclusion Criteria 
Original Wording:  
EXCL02: Does your child currently have (or have a history of) any significant illness or 
chronic medical condition (SITE: that in the opinion of the investigator may 
negatively impact child’s health and/or clinical trial results, for example 
medications to 
treat nocturnal enuresis,antibiotics, antihistamines, anti-
inflammatory medications, corticosteroids, mediations to treat yeast 
infection or similar)? 
EXCL03: Is your child currently using any medications? (SITE: that in the opinion of the 
investigator may negatively impact child’s health and/or clinical trial results)? 
Revised Wording: 
EXCL02: Does your child currently have (or have a history of) any significant illness or 
chronic medical condition (SITE: that in the opinion of the investigator may 
negatively impact child’s health and/or clinical trial results)? 
EXCL03: Is your child currently using any medications? (SITE: that in the opinion of the 
investigator may negatively impact child’s health and/or clinical trial results), for 
example medications to treat  nocturnal enuresis, antibiotics, 
antihistamines, anti-inflammatory medications, corticosteroids, 
mediations to treat yeast infection or similar). 
 
Amended Protocol Sections for #2: 
3.1 Clinical Trial Design 
   Original Wording:  
This will be a single center, single blinded (sponsor’s team will be blinded to the product codes), 
randomized, cross-over, IRB-Approved, in-home clinical test design over 6 weeks, with two usage 
periods of 3 weeks each. 
   Revised Wording:  
This will be a single center, single blinded (sponsor’s statistician and substitute clinical scientist for 
the evaluability meeting will be blinded to the product codes), randomized, cross-over, IRB-
Approved, in-home clinical test design over 6 weeks, with two usage periods of 3 weeks each. 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               27 
Amended Protocol Sections for #3: 
3.1 
Clinical Trial Design 
   Original Wording:  
The order of the NJ EU product and own product will be randomized. 
 Revised Wording:  
The order of the NJ EU product and own product will be randomized. At the end of visit 1, subjects 
will be randomized according to the strata as follows:  gender (M or F) and age (4-5 or 6-7). 
 
3.2.1 Visit 1 – Enrollment and Training (on Site) 
Original Wording:  
5. Subjects will be randomized to one of two usage periods, either starting with their own current product 
or starting with test product. 
Revised Wording:  
5. Subjects will be randomly assigned to begin with either their own product or the test product per a 
stratified randomization plan that utilizes randomization strata based on child’s sex (male or female) and 
age group (4-5 years or 6-7 years). Randomization will be done so approximately 50% (n=16) of subjects 
will begin with their own product and approximately 50% (n=16) of subjects will begin with the test 
product. Product sequence will be assigned from a computer-generated randomization program 
provided by the Sponsor. The sequence of numbers used for the randomization will be 3-digit 
consecutive numbers whose first digit will not be the same as the 4-digit sequence used for subject 
identification (e.g., 301). 
 
Attachment R: COVID or Weather Impact to Clinical Trial Procedures 
3.2.1 Visit 1A – Enrollment (Virtual for Covid) 
Original Wording:  
5. Subjects will be randomized to one of two usage periods, either starting with their own current product 
or starting with test product. 
Revised Wording:  
5. Subjects will be randomly assigned to begin with either their own product or the test product per a 
stratified randomization plan that utilizes randomization strata based on child’s sex (male or female) and 
age group (4-5 years or 6-7 years). Randomization will be done so approximately 50% (n=16) of subjects 
will begin with their own product and approximately 50% (n=16) of subjects will begin with the test 
product. Product sequence will be assigned from a computer-generated randomization program 
provided by the Sponsor. The sequence of numbers used for the randomization will be 3-digit 
consecutive numbers whose first digit will not be the same as the 4-digit sequence used for subject 
identification (e.g., 301). 
 
Amended Protocol Sections for #4: 
3.1 Clinical Trial Design 
    Original Wording:  
Up to 30 children (approximate split of 15 males and 15 females) who meet inclusion/exclusion 
criteria will be enrolled in the clinical trial. 
    Revised Wording:  
Approximately 32 children (approximate split of 16 males and 16 females) who meet 
inclusion/exclusion criteria will be enrolled in the clinical trial. 
 

Clinical Investigational Plan CSD2021096 
Confidential                                          Final Version  
 
 
Print Date:  23 February 2023 
                               28 
Attachment A : Informed Consent: Procedures 
Original Wording:  
Approximately 30 children with nocturnal enuresis (bedwetting) at least once per week will 
participate in this clinical trial. 
Revised wording:  
Approximately 32 children with nocturnal enuresis (bedwetting) at least once per week will 
participate in this clinical trial. 
 
I am in agreement with the Amendment as described: 
 
 
____________________________________________________________________________ 
Laura Huesing Wray (Principal Investigator)   
 
Date 
 
 
_____________________________________________________________________________ 
Dr. Susanna Brink (Clinical Scientist & Sponsor Representative)  Date