Role of the Arts in the Life and Mental Health of Young People That Participate in Artistic Groups in Colombia: a Qualitative Study

Background: Young adults and adolescents are in stage where their mental health is more vulnerable. In Latin América, there are factors that predispose young people towards an increased risk of suffering from mental illness. However more than half of the young people who manifest symptoms of depression and anxiety are able to overcome these episodes approximately one year after the onset of symptoms. This is related to the concept of resilience. Methods: The main objective of the study was to characterize the role of the arts in relation to mental health in young people involved in artistic organizations in Bogota. Six artistic workshops and focus groups were conducted, with 38 participants from two arts organizations in Bogota. The type of artistic workshop varied depending on the type of art taught in each institution. The focus group discussions were recorded, transcribed, coded and analyzed using an inductive analysis methodology. Results: There were ve themes that emerged in explaining the role of the arts in relation to the mental health of young people. These themes included i) the management and expression of emotions, ii) the transformation of emotions, iii) the distracting quality of the arts, iv) the arts as a social facilitator and v) the arts as part of the identity and lifestyle of young people. Conclusions: For young people who participate in artistic activities, the arts are a tool for managing emotions perceived as negative, such as stress, anxiety, depression and sadness. Their perception of the arts as a tool for mental health was viewed differently depending on whether it is perceived as a professional vocation versus a hobby. These ndings are relevant within the context of the COVID-19 pandemic, taking into account that the participants were exposed to various mental health risk factors, such as an extended obligatory quarantine and social distancing.

The World Health Organization have reported that approximately 10-20% of young people have undiagnosed or untreated mental health problems (3). Moreover, it is estimated that by the year 2030, depression will be the leading cause of disease burden globally (6). Evidence suggests that having a mental health problem during adolescence is a risk factor for having other psychiatric problems and are strongly associated with psychiatric disorders in later life (7,8). Likewise, it is important to note that around 75% of mental health illnesses begin before the age of 25 (9). Thus, the mental health of young people should be considered a public health priority (8).
According to the 2015 National Mental Health Survey, in Colombia, the lifetime prevalence of depression or anxiety in adolescents is 2.4% and 5.0% respectively (10). This compares to adults, where the lifetime prevalence of these disorders are 5.3% for depression and 3.9% for anxiety (10). However, it is important to note that between 50-60% of young adults and adolescents who manifest symptoms of depression and anxiety do not develop disorders and are able to overcome these episodes of emotional distress approximately one year after the onset of symptoms (11). This capacity to overcome adversity is associated with some protective factors, such as resilience (11). The present COVID-19 pandemic can be considered an exacerbating factor in relation to the mental health of young people (12). According to a survey conducted by UNICEF in Latin America and the Caribbean region, 27% of young people reported symptoms of anxiety and 15% reported symptoms of depression during the pandemic (13). Moreover, a survey conducted in Bogota, found that 32% of the participants manifested feeling more anxious or nervous compared to before the quarantine, whilst, 27% of participants manifested feeling signi cantly more anxious or nervous after the quarantine (14).
Resilience is de ned as the dynamic process that includes the positive adaptation within a context of signi cant adversity (15), meaning that it is a process that implies overcoming the negative effects of exposure to risk, traumatic events and the evasion of the negative trajectories associated with risks (16). The concept of resilience is also related to the process of recovery in mental health (17). If recovery is considered as the process of adapting and overcoming illness, resilience, within the context of recovery, facilitates individuals to use their abilities and qualities in order to overcome adversity and build a future based on their goals (17). An important aspect of resilience is the presence of factors that aid in generating positive outcomes or avoiding negative ones (16). These factors, also referred to as resources, can originate from different sources (16). There are resources that have been described as intrinsic to the individual, whilst others are considered external (16). The external resources relate to social and cultural aspects that exist in the environment that surrounds people, like, for example, family, interpersonal relationships or participation in activities, such as the arts (18,19).
In relation to the aforementioned, it is important to highlight that the evidence relating the arts and positive health has strengthened. Various reports and reviews in the medical literature have mentioned the bene ts to mental health and community wellness of artistic activities (20). Some studies have concluded that participating in artistic activities, including clinical arts therapy and non-clinical artistic activities, may provide bene ts for mental health and improve wellness in individuals (20). In young people, engaging in these types of activities has been associated with positive outcomes such as the development of social skills and positive behavioral changes (19). This participation has also been associated with increased self-esteem, feelings of achievement, empowerment, social skills and promoting socializing with others (19); all of these characteristics are related to the concept of resilience (19). However, the existing studies and the available evidence in this area, has mainly originated from European countries, meaning that the evidence of the arts and its relation to mental health in young people within a Latin American context, speci cally Colombia, is limited.

Methodology:
Study Design: This study is a qualitative analysis of data collected during the rst phase of a multicentre study called OLA (Building resilience and resources to reduce depression and anxiety in young people from urban neighborhoods in Latin America). This study was conducted simultaneously in three capital cities of different Latin American countries (Bogota, Lima and Buenos Aires).
During the rst phase of this study, focus group discussions with young adults, adolescents and professionals were carried out. In addition to this, artistic workshops with young people who were involved in organizations that promote and teach different types of artistic expressions, like singing, drawing, musical composition, etc., were also executed. This article includes the analysis of the data collected from the artistic workshops in Bogota, Colombia.

Objectives:
The main objective of this study was to characterize the role of the arts in relation to the mental health of young people who are involved in different arts organizations in Bogota. Likewise, the main objective of the artistic workshops was to explore the experiences of overcoming episodes of emotional suffering in young people, including the use of artistic activities, but not focusing solely on them. The participants were recruited from two arts organizations in Bogota: Familia Ayara and Batuta Foundation.

Arts Organizations:
Batuta Foundation is an organization whose main aim is to improve the quality of life of children, adolescents and young people in Colombia through musical education that focuses on collective practice from a social inclusion, rights and a culturally diverse perspective (21). Familia Ayara organization is an institution inspired by the 1980's New York Hip Hop movement. Though the different types of Hip Hop artistic expressions, Familia Ayara seeks to generate spaces where young people can express themselves, generate dialogue and re ect on the problems that affects them (22).
These two organizations helped in the development of the workshops by implementing different artistic methods that were associated with their own practices. The artistic workshops explored the experience of depression and anxiety and the role of the arts in relation to the recovery of emotional suffering.

Participants:
A convenience sampling method was used to recruit participants. This was facilitated by the coordinators of the arts organizations associated with the project, taking into account the interest of the young people who were active in their organizations.
The inclusion criteria included: being 15-24 years old, wanting to participate in artistic activities, being currently active in the activities provided by the arts organization, having the capacity to consent (for those aged18 and over), receiving consent from a parent or legal guardian (for those aged 17 and under) and have capacity to assent (for those aged 17 and under).

Data Collection:
In total, six workshops were conducted: four of them with Batuta Foundation and two with Familia Ayara. The workshops were adjusted to the activities that the participants engaged within these organizations.
Nevertheless, each workshop had two phases: the rst part consisted of ice breakers, explaining the context of the workshop and the use of different artistic activities for self-expression; the second part consisted of a structured conversation with questions for the participants delivered by a moderator. During the second phase of each workshop, the conversation was guided towards identifying the characteristics, resources and activities participants had used to overcome moments of emotional distress. The moderators for these conversations were part of the OLA research team and also mental health professionals at the Ponti cia Universidad Javeriana. On average, the workshops lasted between two and four hours.
Taking into account that the rst phase of the OLA study took place in 2020, the artistic workshops were adapted to a virtual modality in order to comply with the social distancing requirements of the Colombian government due to the COVID-19 pandemic. These workshops were held virtually through the Microsoft Teams platform.

Batuta Foundation: Artistic workshop description
The four workshops conducted with the Batuta Foundation had a total of 20 participants split into 4 groups ( ve participants per group).. The workshops were facilitated by members from both, the OLA research team and Batuta Foundation, the latter were present to assistant with the structure, guidance and execution of the workshops, particularly in relation to the artistic activities held.
The artistic activities held during the workshops are described below: Introduction round: The participants introduced themselves and were asked to perform a body movement that would identify them.
Sounding Scenery: The participants had to relate sounds that were played to images displayed for them.
Learning song lyrics: With the help of one of the organization teachers, the participants had to repeat the lyrics to the song "Yenyeré Gumá" whilst the instructor sang simultaneously.
Changing the lyrics of known songs: The song "Color Esperanza" by Diego Torres was played and the participants had to listen and then jointly write new lyrics for the melody of the song. The lyrics had to be in relation to the words mentioned after they were asked "What has music meant for you in your life?".
After each activity, the participants provided a word describing their feelings during the activity.

Familia Ayara: Artistic workshop description
The workshops conducted with Familia Ayara had a total of 17 participants, who were divided in two groups. Bearing in mind the variety of artistic activities that this institution provides, the workshops had different approaches towards the arts. One of them included activities related to the rap musical genre and the other one with gra ti art. During these workshops members of the research team were present, as well as a teacher and a member of the psychosocial department of the organization. These last two individuals helped in guiding the workshop.

i. Rap Workshop:
During this workshop the following activities were held: Introduction round: The participants presented themselves through a rap improvisation.
Rap composition and socialization: The participants chose one of three music tracks to work with and composed rap lines with 8 beats each. The themes of the rap lines related to premises of selfrecognition, emotions, life projects and stress management. After the composition period, the participants were asked to share their compositions.
The participants provided a word describing how they felt before and during the workshop.
ii. Gra ti Workshop: During this workshop the following activities were held: Introduction round: The participants, members of the organization and research team introduced themselves.
Word transformation through drawing: The participants were asked to think of a word that represented a negative emotion they felt during the pandemic and quarantine. After, the participants were asked to write this word using separate strokes so that the lines that formed the words did not touch. Lastly, they were asked to transform each line into a positive image through a drawing.
Focus group discussions with the participants (both institutions): During the second phase of each artistic workshop, conversations were held with the participants in relation to the role of the arts in their lives, their mental health and the tools they used to overcome moments of emotional distress. The objectives of these conversations were to explore the representations of depression and anxiety using artistic methodologies; to identify and describe physical, affective, cognitive, behavioral and social manifestations of depression and anxiety according to their experience; and to describe the main causes of emotional suffering. These conversations lasted between 60 and 80 minutes.

Data Analysis:
The focus group discussions were recorded in audio format, transcribed and analyzed using an inductive thematic analysis methodology proposed by Braun and Clarke (ref). Three researchers familiarized themselves with the transcriptions and generated a coding and thematic scheme that re ected the role of the arts within the participants´ lives and its relation to their mental health. The themes and codes were discussed with the research team and modi ed iteratively. Afterwards, two research team members applied the coding scheme to the transcriptions using NVivo 12 ® qualitative software. During the coding process, an initial coding scheme was made, which yielded a de nitive version following team review and discussion.
After coding all of the transcriptions, a report that describes the content of each code was generated and this was the basis for the result synthesis.

Ethics
All methods and instruments used during this process were revised and approved by the research and ethics committee of Queens Mary University in London and by the research and ethics committee of San Ignacio University Hospital of Ponti cia Universidad Javeriana. The aforementioned follows the established protocols of the Good Clinical Practice guidelines according to the Colombian legislation. The analysis plan was elaborated and signed by the principal researchers previous to the process. None of the interviews were corrected or repeated. The data as collected during August and September of the year 2020.

Results:
A summary of the demographic characteristics of the participants in relation to their age range, sex and the artistic workshop they attended can be found in Table 1. Five categories were identi ed from the workshops: 1) They mobilize emotions and facilitate their expression; 2) They help to manage or transform di cult emotions; 3) They distract from problems; 4) They allow the creation of spaces for social support and facilitate social relations; 5) They contribute to the construction of identity and lifestyle. The ve categories are shown in Table 2 where the categories correspond to the rst row and each column resumes the codes used in each category. As mentioned previously, this study was conducted during the COVID-19 pandemic, therefore, within the results a section alluding to the emotional experiences of the participants during this period was included, taking into account that they are a factor to consider when talking about their mental health. One of the most frequent theme that emerged about the role of artistic activities in relation to their mental health, is the ability to communicate their emotions and thoughts through arts. Several young people mentioned that artistic expressions have allowed them to vent or unload their worries or negative thoughts. In some cases, it has helped them overcome certain di culties they have had in recognizing and verbally expressing what they are feeling. Others take advantage of writing, musical composition or painting as a means of understanding and clarifying di cult situations, particularly when they are unwilling to talk about them with friends or family, due to mistrust or fear of being judged. Additionally, some young people have found in Hip Hop a vehicle to make known their views and thoughts about their lives and the reality of the country.
"I think it is a way of expressing oneself. Then each one can transmit or express, as my colleague said before, something that one feels personally. Then, from that, you can vent, either on a wall, or on a piece of paper. And so, one is a little freer to express what one feels through art, or through something that one practices. So, it's like, I don't know, like making something that one feels known, very inwardly through something one knows how to do or likes." (Familia Ayara, F, 19 years old) "I feel that I would lose a lot of stability, uh, on an emotional level. I feel that it is the only thing that keeps me in order and, let's say, healthy, right? Speaking of this topic, which is art. A distraction from problems Some participants claimed that attending music workshops or playing an instrument helps them to distract themselves, forget problems and di culties. According to their description, through artistic activities, distraction seems to encompass multiple psychological aspects described as "having a more active mind", "putting the mind in blank", "getting away from reality", or "feeling in another world". They allow the creation of spaces for social support and facilitate social relations The participants interviewed highlighted the opportunity offered by artsorganizations to explore their interests or discover artistic activities and languages. They have also found in them different forms of social support. Familia Ayara has provided a space to meet with young people who share their interests, which has helped individuals to overcome feelings of being "out of place". For their part, those who are part of Batuta Foundation consider it an important space to meet other people and create bonds of friendship with their peers. Teachers, facilitators and psychosocial support staff also represent an important support for some of the participants.
"When I'm not feeling well, I go and talk to the assistant and the psychosocial worker. And in spite of that, in the 8 years that I have been at Batuta, I have formed bonds of friendship. I have seen people come and go, and I could always count on them, but some of them left and others never came back. And well, that's how it has helped me: to learn that people are not always there, but if you look for them, I believe they will be there". (Batuta, M, 17 years old) Furthermore, some participants involved with Batuta Foundation see music as a way to connect with others. They say that the ease of expression they develop through musical performance has helped them to communicate, especially those who nd it di cult to socialize. Others note that music has favored cohesion with their fellow orchestra members.
"If art did not exist, I think there would be a lack of union between human beings, because through art one can..., as you were saying, a harmony is generated, or a connection with other people. Or, for example, in my musical experience, while you make music you connect... You enter another reality, so to speak, for a moment and that is something very cool that would be lost if art did not exist". (Batuta, F, 18 years old) They contribute to the construction of identity and sense of purpose Rapping and playing a musical instrument has also helped some participants to get to know themselves better, as well as to recognize their strengths and weaknesses. In some cases, facing an audience has allowed them to gain con dence.
"Well, before learning about music, I was con dent about playing sports [.

Emotional implications of the COVID-19 Pandemic
When probed about how they have experienced the pandemic quarantine period, and the possible effects this has had on their mental health, some participants mentioned that this led to feelings of insecurity and frustration, usually related to the di culty of making plans or trusting that their projects will come to fruition.
"I think the rst thing it has taught us since the pandemic started is that nothing is certain, no... no jobs, not what you want to do, not the plans to leave. As they say, the only thing that is certain is that we are going to die, nothing in this life is certain, plans can change from one day to the next." (Familia Ayara, M, 22 years old) One participant recounted how painting allowed her to work out her uncertainty about leaving her job just prior to the onset of the pandemic.
"After three days they said that no one could leave, everyone was in con nement. I was left with my arms crossed and I said, what am I going to do now? where am I going to get a job? So, I said, well, while something comes up, let's wait. And well, I took paper and watercolors and in reality, I wasn't feeling good, but I wanted to use the time. I felt that, well, in the rst brushstrokes when I had already done the face, I said: I don't know, it's not re ecting what I want. So, I had a xed point and I said: no, I want it to re ect sadness, because that's how I feel [...] So, let's say that it is something satisfying when you do something with a purpose, with an end and it has the expected results." (Familia Ayara, F, 17 years old) Additionally, some participants have had to get used to a decrease in academic, work and leisure activities. Although several participants continued to take part in artistic activities, others put them on hold. In the case of the Batuta Foundation, the participants did not have access to the musical instruments provided by the organization; while, as a result of the mobility restrictions established during the pandemic, some participants linked to Familia Ayara limited their outings to gra ti related activities.
Other participants considered that this change has been positive, as they have reduced the activities that caused them stress, such as the use of public transportation or the ful llment of schedules and obligations, which has allowed them to dedicate more time to activities that interest them or consider pleasurable.
"At the beginning of my quarantine it was di cult for me to stay here at home because I was busy every day of the week. Monday through Friday I would go to school, Saturdays I would do some activity and on Sundays another one. So, to be in constant movement and then to stop, technically, because of the pandemic, well, it was di cult. But now [...] I am more used to being in four walls. And I avoid overexposing myself, and like I don't feel like anything gives me enough security, because it's always going to happen like something bad. I'm like always on the defensive and watching to see what happens." (Batuta Foundation, M, 17 years old) Discussion: We were able to identify and explain how the arts help young people cope with emotional distress and how arts organizations can provide psychological and social support. Despite the differences between the institutions and their artistic methodologies, we found similarities in the mechanisms that the participants identi ed in relation to art and the mental health bene ts it provides.
Emotion management and its relationship with the arts: We found that the arts are useful for the mobilization and expression of emotions, particularly when the emotions are perceived as negative, and they also help young people to recognize and manifest how they feel. The results suggest that not all artistic activities evoke the same emotions, and that this depends on the type of artistic activity being performed. For example, writing seems to serve a more internal purpose, related to understanding emotions, while other activities, such as musical performance, gra ti, painting or rapping, contribute to externalizing thoughts and feelings.
Likewise, it was found that artistic expression can help to manage psychological states such as stress, anger, depression and anxiety, since it provides a way to transform them. Although the recognition or venting of emotions and their transformation seem to be strongly linked, these aspects were analyzed in different categories. It should be clari ed that delving into the difference between the psychological process of recognizing and relieving emotions or transforming them is not part of the objectives of this study, thus this difference was not addressed in depth.
In relation to the transformation of emotions, within the Familia Ayara workshops the creativity was evidenced through the gra ti activity. In this activity, the participants made a drawing that narrated a signi cant story, starting with a word that re ected a negative emotion drawn with separate strokes, with the purpose of changing the meaning of the word. This process leads not only to creativity and expression of the individual's emotional state, but also to the reconstruction of situations and emotions in a comprehensive way for the individual. It should be noted that this technique of combining the writing of words and transforming them into drawings is reminiscent of the technique described by Winnicott, in which the patient elaborates a trace that culminates in a gure or vice versa, giving a story understood within the personal history of the individual (23). This has also been reported to be effective in the context of child therapy (24,25).
Participants stated that artistic activities, such as attending music workshops or playing an instrument, are a source of distraction and help them forget about problems or di culties. Distraction seems to be a multidimensional category, distraction occurs in relation to other aspects of the arts, such as pleasure and the meditative nature of the arts, among others. Additionally, distraction from problems and emotional management through artistic activities are closely linked, since distraction as a result of these activities could be considered a way of managing emotions. It is important to understand that the strategies used by young people to manage negatively perceived emotions, for some, and depending on the situation, distraction may be more useful, while for others it is more useful to vent or confront them.
Nonetheless, more studies are needed to have a better understanding of the aforementioned. Taking into account all of the above, the arts, by serving as a vehicle for emotions, could have a preventive role in the development of mental health problems in young people, or serve as a therapeutic exercise when there is di culty in expressing negatively perceived emotions.
The ndings discussed in this section regarding the arts and their relationship with the emotional dimension of the participants are consistent with ndings from other studies that analyze the bene ts of arts activities for mental health in both adult and youth populations (19,20,26,27). Some of the bene ts found in the literature include self-expression, expression of feelings, distraction from illness/problems, and a perceived improvement in mental health well-being (19,20,26,27).
Personal and professional identity in relation to the arts: Throughout the study we found that the participants perceive their relationship with the arts differs according to the approach and vision of art taken within each organization. Several participants from the Familia Ayara see art as a lifestyle and as an integral part of their identity, and likewise perceive art as a professional vocation, rather than as a hobby or pastime. This is consistent with some of the bene ts of the arts found in another study with young people, such as security, a sense of belonging, and the development of social skills (19). This point of view was not re ected among the participants from the Batuta Foundation, although some of them mentioned how they identi ed with musical performance or considering it as a professional career option. To understand this, it should be noted that the Familia Ayara works around an artistic expression that is part of a broader cultural framework: Hip Hop. Through this, the organization not only invites young people to develop different artistic practices (rap, gra ti and break dancing), providing them with important technical support, but they also offer active psychosocial support. This may re ect the way in which the Familia Ayara participants perceive art in their lives. However, future studies are needed to explore the role of the arts in the mental health of people who perceive the arts as a career and those who use the arts as a hobby.
COVID-19 Pandemic and the arts: One aspect to consider in this study is the impact of the COVID-19 pandemic. Firstly, the impact of the pandemic has led to a substantial worsening in the mental health of young people worldwide, which must be taken into account. (12). Therefore, we could assume that the participants in this study, having undergone a considerably long period of social isolation and mandatory quarantine (6 months) (28), were particularly susceptible to symptoms of depression and anxiety. Participants also mentioned that, in some cases, the restrictions imposed by the pandemic made it di cult for them to engage in artistic activities. However, we believe that the participants who continued to actively participate in some form of art during lockdown or the self-isolation period, that this acted as additional emotional support which prevented or mitigated symptoms of depression and/or anxiety. Finally, it should be noted that the activities included in this study allowed the participants to interact socially for the rst time since con nement, which they described as an exciting experience.

Strengths And Limitations:
To our knowledge, this is the rst study to explore how the arts help young people to cope with emotional distress in a Latin American country, such as Colombia. An important strength of our study is the variety of artistic expressions used among participants -music composition, rap, gra ti, singing, etc. -which allowed us to gain a deeper understanding of the different ways in which arts and arts organizations can support young people in overcoming mental and emotional distress.
Another strength of the study is the arts organisations ability to adapt and be exible during the COVID-19 pandemic. Initially, all the artistic activities (related to music, rap, gra ti, etc.) were planned to be conducted in-person, but due to the restrictive measures implemented in Bogota, these had to be adapted and conducted on virtual platforms. Even though the virtual execution of the activities proved challenging, it was also interesting to see how each organization was creative enough to adapt their methods by using innovative strategies.
Interestingly, we were also able to capture some of the experiences of isolation due to the quarantines and changes in the social dynamics (family, friends, academic environment, etc.) due to the COVID-19 pandemic. A nding that was not anticipated during the design of the study.
Nevertheless, this study also had some limitations. Conducting focus groups and arts workshops virtually may have in uenced the interaction between the facilitators and the participants, and impacted the comfort and openness to discuss certain topics. Despite this, the data collected was rich and varied, allowing us to better understand the role of arts in overcoming mental and emotional distress among young people. Finally, it is important to consider that our ndings may only apply to the context of urban settings such as Bogota. Additional research is needed to understand how the arts help young people cope with emotional distress in more rural settings.

Conclusions:
Study participants stated that the arts are a broad dimension of their personal experience and that they can serve as a tool for managing negatively perceived emotions, such as stress, anxiety, depression, and sadness. The management of these emotions can occur in different ways, either because the arts help to transform these emotions, or because it helps young people to vent or express what they are feeling. Furthermore, the arts serves as a means of distraction for some people. However, even though these three ways of emotional management overlap, the psychological processes that are behind each one appears to be distinct. Therefore, we consider that the differences in these processes should be studied further.
Likewise, it was found that there are differences in the perception of the arts as a tool for mental health when art is perceived as a professional vocation versus when it is considered as a hobby. This is also related to the vision instilled by the art institutions and the type of artistic disciplines they teach. Although the participants of both organizations mention art as an important part of the construction of their identity and professional vocation, this is more accentuated in the participants of Familia Ayara. It is considered necessary to clarify the relationship between the perception of art as a vocation and identity and what it can contribute in terms of mental health through long-term studies.
It should be noted that these ndings are relevant within the COVID-19 pandemic context, given that the activities in this study took place during a time when young people were exposed to mental health risk factors such as extended mandatory quarantine and social isolation. Finally, the ndings of this study suggest that artistic activities, such as composition, drawing, writing, music performance, and hip hop, are both a support and an emotional tool for youth who engage in these types of activities.

Declarations:
Ethics approval and consent to participate: Written approval was received for this study from the Faculty of Medicine -Research and Ethics Committee of the Ponti cia Universidad Javeriana, Bogota on 20/03/2020 (FM-CIE-0241-20) and from the Queen Mary Ethics of Research Committee on 16/11/2020 (QMERC2020/02). All methods were carried out in accordance with relevant guidelines and regulations. All informed consent/assent was obtained from all subjects and/or their legal guardian(s) for participants aged less than 16 years.