This is an online clinical research study. You will be asked to register today and then to complete the survey questions. Then, you will be asked to re-answer the same survey questions every 30 days for the next 90 days. So, a total of three more times.
There are 3 parts to this survey:
1. This registration page. It is the most burdensome and takes the longest to complete. You will not be asked to complete it again.
2. Questions wherein you will select answers to simple, general health questions. You will complete this page four times - once today and once every 30 days for 90 days.
3. A page of gender-specific sexual function questions wherein you will select answers to questions related to your sexual health. You will complete this page four times - once today and once every 30 days for 90 days.
You have an opportunity to participate in a clinical research study. The purpose of this consent form is to give you the information you will need to help you decide if you want to be in the study. Please read the form carefully. You may ask us or your doctor questions about the purpose of the research, what we would ask you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this form that is not clear. When we have answered all your questions, you can decide if you want to be in the study or not. This process is called 'informed consent.' You are welcome to print a copy of this form for your records.
This consent form may contain words that you do not understand. Please ask us to explain any words or information that you do not clearly understand. You may print a copy of this consent form to think about or discuss with family or friends before making your decision.
1. You will register for the study by providing personal contact and health information.
2. You will be asked questions about your overall health and disposition. The questions will cover how you feel and will include direct questions about your sexuality. Men and women will be asked similar and different questions.
3. After completing the registration and the initial survey, we will send a 90 day supply (3 bottles) of Stronvivo to you in exchange for your promise to answer the survey questions today and again after approximately 30 days, 60 days and 90 days.
4. For each 30 day survey, we will send an email to you providing a link to the survey questions and a reminder to complete the next survey.
5. You agree to take Stronvivo as instructed daily and on time and agree to provide feedback at the end of each 30 day period.
6. Each of the survey questions requires only a click to select the answer. After the initial time, the monthly surveys take less time to complete as we do not request the registration information again and you are more familiar with the questions and answer choices. That said, we respectfully request that you go slow enough to provide thoughtful feedback.
7. We will use your contact information to contact you and to send Stronvivo to you.
8. We will use your health information to categorize and classify the survey responses (e.g. In men of this certain age range, Stronvivo had the following benefit...).
9. We will use your survey answers without your name attached to draft research papers, analyze results, identify patterns in the data, present results/answers to others by publication and in all other ways, to market and sell Stronvivo and other related products; and to improve Stronvivo. Further, you give us permission to share your answers with our affiliates or other researchers and for those entities to use your answers in the same ways, including for publication or other uses.
10. We will provide to you any information developed during the study that might affect your willingness to take part in the study.
RISKS, STRESSES, AND DISCOMFORTS:
1. In the event of side effects or overdose; you will contact 911, your doctor, or another healthcare provider. You will not contact us for medical advice or treatment.
2. It is possible that we, and consequently you, could suffer a breach of confidentiality and that your personal information could be disclosed. We will not sell your data to an unaffiliated party independent of selling our company.
3. There may be side effects that are unknown.
4. Consult your doctor before participating if you are pregnant or breast-feeding as the risks and potential consequences have not been investigated or evaluated.
5. If you have had a heart attack or stroke, consult with your cardiologist before participating in this study.
6. Your condition may not get better or may become worse while you are in this study.
7. Only you can take the Stronvivo obtained through the study. It must be kept out of reach of persons who may not be able to understand the label.
1. You may feel better as a result of your participation in this study. However, there is no guarantee of this.
2. You may feel more alert when you wake up as a result of your participation in this study. However, there is no guarantee of this.
3. You may have more energy as a result of your participation in this study. However, there is no guarantee of this.
4. You may have more sexual desire and sexual energy as a result of your participation in this study. However, there is no guarantee of this.
5. Your endothelium may become healthier as a result of your participation in this study. However, there is no guarantee of this.
6. Your high blood pressure may decrease to a more healthy level as a result of your participation in this study. However, there is no guarantee of this.
7. Your level of bad cholesterol may decrease as a result of your participation in this study. However, there is no guarantee of this.
8. You may have a lowered risk of cardio vascular disease as a result of your participation in this study. However, there is no guarantee of this.
9. You may sleep better as a result of your participation in this study. However, there is no guarantee of this.
10. You may be more resistant to and suffer less from the common cold infection as a result of your participation in this study. However, there is no guarantee of this.
11. You may have better circulation as a result of your participation in this study. However, there is no guarantee of this.
12. You may become healthier as a result of your participation in this study. However, there is no guarantee of this.
This is not a treatment study. Your alternative is to not take part in this study.
VOLUNTARY PARTICIPATION AND WITHDRAWAL:
Being in this study is voluntary. You may decide not to take part or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled. We may take you off this study at any time without your consent.
In the upper right corner of the survey, there is a button marked 'Cancel participation.' You may click this button at any time and, if clicked, the answers that you have given in that partially completed survey will not be saved. In order to save your answers, you must click submit at the end of the survey.
By voluntarily participating in this study, you are agreeing that we can use your data for our benefit (including but not limited to publication, marketing, and product improvement) and you are giving up all claims to any money obtained by us or our affiliates from commercial or other use of your data or the research results.
1. You agree that you have read the information in this consent form (or it has been read to you), that all your questions about the study and your part in it have been answered and that you freely consent to take part in this research study without reservation.
2. Except for the rights and things that you have waived above, you will not lose any of the legal rights that you would otherwise have as a subject in a research study.
3. You agree that you are subscribing your email address to our email system and that we may send emails to you that welcome, confirm, reminding, inform, request, and advertise. Anytime after you receive an email confirming your subscription, you will be able to unsubscribe. However, you will not be able to unsubscribe from survey reminder emails or study related emails until this research has concluded.
4. You agree and understand that the number of participants in the study is limited and that by enrolling you are blocking someone else from enrollment. As such, you agree that you will participate for the full duration, take your Stronvivo every day as directed, and provide a total of no fewer than four surveys with each one to be submitted approximately 30 days after the prior submission.
5. Finally, you agree that filling in the information requested below and clicking the Next Page button is your formal assent to and agreement with this consent form. Your assent is irrevocable. We are actually and reasonably relying upon information that you provide.
By clicking the Next Page button you agree that; (a) you are entering into a contractual relationship with the makers of Stronvivo as detailed above, (b) you have no unanswered questions, and (c) you are participating voluntarily.
If there is something that you do not understand or if there is something to which are are not comfortably agreeing; please do not click the Next Page button.